This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

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Resource Profile: Manufactured Drug Product

The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.

Usage:

• Refer to this Resource Profile: eCTD Product Description and Composition
• Examples for this Resource Profile: ManufacturedItemDefinition/a8316fc9-8ca8-4115-81c1-9f8f84c99149

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	Unique identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm
coding		0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
Slices for property	S	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:OvrRelsProf	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Overall Release Profile
coding		0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:OvrRelsMech	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Overall Release Mechanism
coding		0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatInd	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
Slices for value[x]		1..1	boolean	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueBoolean	S	1..1	boolean	Product Coating Indicator
property:LayCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Tablet Layer Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Tablet Bead Type Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Capsule Shell Part Classification Category
coding		0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Capsule Constituent Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	S	1..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
Slices for value[x]		1..1	Attachment	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueAttachment	S	1..1	Attachment	Product Schematic
property:WgtTyp	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Weight Type
coding		0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
property:TotWgtNum	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Total Weight Numeric Numerator
code		0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Total Weight Numeric Denominator
code		0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
value[x]	S	1..1	markdown	A value for the characteristic
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	S	1..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
type	S	1..1	CodeableConcept	Product Part Type
coding		0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function
text	S	0..1	string	Product Part Function Description
amount
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	S	1..1	decimal	Product Part Total Weight Numeric Numerator
unit	S	1..1	string	Product Part Total Weight Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
amount	S	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	S	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
unit	S	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	S	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	S	0..1	string	Plain text representation of the concept
Slices for function	S	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
coding	S	1..1	Coding	Code defined by a terminology system
function:Category	S	1..1	CodeableConcept	Product Part Ingredient Component Function Category
coding		0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
function:Function	S	0..1	CodeableConcept	Product Part Ingredient Function
coding		0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	S	3..*		General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	S	1..1	CodeableConcept	A value for the characteristic
coding		0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	S	1..1	string	Product Part Identifier
property:PPiDref	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Identifier Reference
property:RelsProf	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
value[x]	S	1..1	CodeableConcept	Product Part Release Profile
coding		0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:RelsMech	S	0..1	BackboneElement	General characteristics of this component
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
value[x]	S	1..1	CodeableConcept	Product Part Release Mechanism
coding		0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatPurpose	S	0..*	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
value[x]	S	1..1	CodeableConcept	Coating Product Part Purpose
coding		0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
property:Color	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Color Description
property:ContPercent	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
value[x]	S	1..1	Quantity	Product Part Content Percent
property:AddInfo	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	0..*		A component that this component contains or is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
Slices for property	SΣ	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
property:OvrRelsProf	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Profile
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Mechanism
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
Slices for value[x]	Σ	1..1	boolean	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueBoolean	SΣ	1..1	boolean	Product Coating Indicator
property:LayCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Tablet Layer Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Tablet Bead Type Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Capsule Shell Part Classification Category
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Capsule Constituent Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
Slices for value[x]	Σ	1..1	Attachment	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueAttachment	SΣ	1..1	Attachment	Product Schematic
property:WgtTyp	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Weight Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Total Weight Numeric Denominator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SΣC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
text	SΣ	0..1	string	Product Part Function Description
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SΣC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
amount	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
coding	SΣ	1..1	Coding	Code defined by a terminology system
function:Category	SΣ	1..1	CodeableConcept	Product Part Ingredient Component Function Category
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	SΣ	3..*	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Identifier Reference
property:RelsProf	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Profile
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Mechanism
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	Coating Product Part Purpose
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Color Description
property:ContPercent	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
value[x]	SΣ	1..1	Quantity	Product Part Content Percent
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type	example	Pattern: RelsProf("Product Part Release Profile") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	Pattern: RelsMech("Product Part Release Mechanism") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	Pattern: CoatPurpose("Coating Product Part Purpose") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.type	example	Pattern: Color("Product Part Color Description") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:ContPercent.type	example	Pattern: ContPercent("Product Part Content Percent") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:OvrRelsProf	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Profile
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:OvrRelsMech	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Mechanism
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CoatInd	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	boolean	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueBoolean	SΣ	1..1	boolean	Product Coating Indicator
property:LayCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Tablet Layer Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Tablet Bead Type Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Capsule Shell Part Classification Category
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CapConCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Capsule Constituent Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	Attachment	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueAttachment	SΣ	1..1	Attachment	Product Schematic
property:WgtTyp	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Weight Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:TotWgtNum	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Total Weight Numeric Denominator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	markdown	A value for the characteristic
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	Extension	Additional content defined by implementations
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SΣC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Product Part Function Description
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SΣC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
amount	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
function:Category	SΣ	1..1	CodeableConcept	Product Part Ingredient Component Function Category
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	SΣ	3..*	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Identifier Reference
property:RelsProf	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Profile
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:RelsMech	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Mechanism
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CoatPurpose	SΣ	0..*	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Coating Product Part Purpose
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:Color	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Color Description
property:ContPercent	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	Product Part Content Percent
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ManufacturedItemDefinition.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type	example	Pattern: RelsProf("Product Part Release Profile") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	Pattern: RelsMech("Product Part Release Mechanism") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	Pattern: CoatPurpose("Coating Product Part Purpose") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.type	example	Pattern: Color("Product Part Color Description") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:ContPercent.type	example	Pattern: ContPercent("Product Part Content Percent") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 33 elements(24 nested mandatory elements)
Must-Support: 96 elements

Structures

This structure refers to these other structures:

• Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.property.value[x]
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.function (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)

Differential View

This structure is derived from ManufacturedItemDefinition

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
meta
profile	S	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
identifier	S	0..1	Identifier	Unique identifier
status	S	1..1	code	draft | active | retired | unknown
name	S	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm
coding		0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
Slices for property	S	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:OvrRelsProf	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Overall Release Profile
coding		0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:OvrRelsMech	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Overall Release Mechanism
coding		0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatInd	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
Slices for value[x]		1..1	boolean	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueBoolean	S	1..1	boolean	Product Coating Indicator
property:LayCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Tablet Layer Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Tablet Bead Type Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Capsule Shell Part Classification Category
coding		0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Capsule Constituent Count
code		0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	S	1..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
Slices for value[x]		1..1	Attachment	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueAttachment	S	1..1	Attachment	Product Schematic
property:WgtTyp	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Weight Type
coding		0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
property:TotWgtNum	S	1..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Total Weight Numeric Numerator
code		0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
value[x]	S	1..1	Quantity	A value for the characteristic
value		0..1	decimal	Product Total Weight Numeric Denominator
code		0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
value[x]	S	1..1	markdown	A value for the characteristic
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	S	0..1	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	S	1..*	BackboneElement	General characteristics of this item
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
Slices for value[x]		1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept	S	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
type	S	1..1	CodeableConcept	Product Part Type
coding		0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function
text	S	0..1	string	Product Part Function Description
amount
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	S	1..1	decimal	Product Part Total Weight Numeric Numerator
unit	S	1..1	string	Product Part Total Weight Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
amount	S	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	S	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
unit	S	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
code	S	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	S	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	S	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	S	0..1	string	Plain text representation of the concept
Slices for function	S	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
coding	S	1..1	Coding	Code defined by a terminology system
function:Category	S	1..1	CodeableConcept	Product Part Ingredient Component Function Category
coding		0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
function:Function	S	0..1	CodeableConcept	Product Part Ingredient Function
coding		0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
hasIngredient	S	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	S	3..*		General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	S	1..1	CodeableConcept	A value for the characteristic
coding		0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	S	1..1	string	Product Part Identifier
property:PPiDref	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Identifier Reference
property:RelsProf	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
value[x]	S	1..1	CodeableConcept	Product Part Release Profile
coding		0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:RelsMech	S	0..1	BackboneElement	General characteristics of this component
type		1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
value[x]	S	1..1	CodeableConcept	Product Part Release Mechanism
coding		0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatPurpose	S	0..*	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
value[x]	S	1..1	CodeableConcept	Coating Product Part Purpose
coding		0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
property:Color	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
value[x]	S	1..1	CodeableConcept	A value for the characteristic
text	S	1..1	string	Product Part Color Description
property:ContPercent	S	1..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
value[x]	S	1..1	Quantity	Product Part Content Percent
property:AddInfo	S	0..1	BackboneElement	General characteristics of this component
type	S	1..1	CodeableConcept	A code expressing the type of characteristic Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]		0..1	markdown	Product Part Additional Information
component	S	0..*		A component that this component contains or is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
meta	Σ	0..1	Meta	Metadata about the resource
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
Slices for property	SΣ	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
property:OvrRelsProf	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Profile
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:OvrRelsMech	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Mechanism
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatInd	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
Slices for value[x]	Σ	1..1	boolean	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueBoolean	SΣ	1..1	boolean	Product Coating Indicator
property:LayCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Tablet Layer Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Tablet Bead Type Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Capsule Shell Part Classification Category
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
property:CapConCnt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Capsule Constituent Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
Slices for value[x]	Σ	1..1	Attachment	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueAttachment	SΣ	1..1	Attachment	Product Schematic
property:WgtTyp	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Weight Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
property:TotWgtNum	SΣ	1..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
value[x]	SΣ	1..1	Quantity	A value for the characteristic
value	Σ	0..1	decimal	Product Total Weight Numeric Denominator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
value[x]	SΣ	1..1	markdown	A value for the characteristic
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	SΣ	0..1	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	SΣ	1..*	BackboneElement	General characteristics of this item
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SΣC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
text	SΣ	0..1	string	Product Part Function Description
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SΣC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
amount	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
coding	SΣ	1..1	Coding	Code defined by a terminology system
function:Category	SΣ	1..1	CodeableConcept	Product Part Ingredient Component Function Category
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	SΣ	3..*	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Identifier Reference
property:RelsProf	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Profile
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
property:RelsMech	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Mechanism
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
property:CoatPurpose	SΣ	0..*	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
value[x]	SΣ	1..1	CodeableConcept	Coating Product Part Purpose
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
property:Color	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
text	SΣ	1..1	string	Product Part Color Description
property:ContPercent	SΣ	1..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
value[x]	SΣ	1..1	Quantity	Product Part Content Percent
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type	example	Pattern: RelsProf("Product Part Release Profile") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	Pattern: RelsMech("Product Part Release Mechanism") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	Pattern: CoatPurpose("Coating Product Part Purpose") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.type	example	Pattern: Color("Product Part Color Description") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:ContPercent.type	example	Pattern: ContPercent("Product Part Content Percent") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ManufacturedItemDefinition	C	0..*	ManufacturedItemDefinition	The definition and characteristics of a medicinal manufactured item, such as a tablet or capsule, as contained in a packaged medicinal product cmc-capsule-count-required: Capsule constituent count is required when the dosage form is 'Capsule' cmc-arbitrary-unit-text-required: BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual cmc-coating-indication-required: Coating indication is required when the dosage form is a tablet, lozenge or capsule cmc-tablet-layer-count-required: Tablet layer count is required when the dosage form is a tablet cmc-tablet-bead-count-required: Tablet bead count is required when the dosage form is a tablet cmc-capsule-classification-required: when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary Name
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ManufacturedDoseForm (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Manufactured Dose Form Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: UnitOfPresentation (example): The presentation type in which an administrable medicinal product is given to a patient.
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item, one of several possible
marketingStatus	Σ	0..*	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
ingredient	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Slices for property	SΣ	5..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type
property:All Slices				Content/Rules for all slices
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1		A value for the characteristic
valueCodeableConcept			CodeableConcept
valueQuantity			Quantity
valueDate			date
valueBoolean			boolean
valueMarkdown			markdown
valueAttachment			Attachment
valueReference			Reference(Binary)
property:OvrRelsProf	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Profile
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Profile
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:OvrRelsMech	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: OvrRelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Overall Release Mechanism
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Overall Release Mechanism
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CoatInd	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatInd
display		1..1	string	Representation defined by the system Fixed Value: Coating Indicator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	boolean	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueBoolean	SΣ	1..1	boolean	Product Coating Indicator
property:LayCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TabLayCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Layer Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Tablet Layer Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:BeaTypCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: BeaTypCnt
display		1..1	string	Representation defined by the system Fixed Value: Tablet Bead Type Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Tablet Bead Type Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:CapClass	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapClass
display		1..1	string	Representation defined by the system Fixed Value: Capsule Classification Category
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Capsule Shell Part Classification Category
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Capsule Shell Classification Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CapConCnt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CapConCnt
display		1..1	string	Representation defined by the system Fixed Value: Capsule Constituent Count
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Capsule Constituent Count
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Required Pattern: C66832
property:Schematic	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Schematic
display		1..1	string	Representation defined by the system Fixed Value: Product Schematic
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	Attachment	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueAttachment	SΣ	1..1	Attachment	Product Schematic
property:WgtTyp	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: WgtTyp
display		1..1	string	Representation defined by the system Fixed Value: Product Weight Type
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Weight Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Strength Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:TotWgtNum	SΣ	1..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtNum
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Numerator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtDen	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtDen
display		1..1	string	Representation defined by the system Fixed Value: Product Total Weight Numeric Denominator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
value	Σ	0..1	decimal	Product Total Weight Numeric Denominator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	ΣC	0..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
property:TotWgtTxt	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtTxt
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Textual
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	markdown	A value for the characteristic
id		0..1	string	xml:id (or equivalent in JSON)
extension		0..*	Extension	Additional content defined by implementations
value		0..1	markdown	Product Total Weight Textual
property:TotWgtOper	SΣ	0..1	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: TotWgtOper
display		1..1	string	Representation defined by the system Fixed Value: Total Weight Operator
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Total Weight Operator Binding: Strength Operator Terminology (required)
property:QualStd	SΣ	1..*	BackboneElement	General characteristics of this item
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: Code System PQCMC Product Characteristic (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: QualStd
display		1..1	string	Representation defined by the system Fixed Value: Quality Standard
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	Σ	1..1	CodeableConcept	A value for the characteristic Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept	SΣ	1..1	CodeableConcept	Product Quality Standard Binding: Quality Benchmark Terminology (required)
component	SΣC	1..*	BackboneElement	Physical parts of the manufactured item, that it is intrisically made from. This is distinct from the ingredients that are part of its chemical makeup cmc-ppidref-required: A PPiDref is required when the PPiD is designated a child.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	Product Part Type
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Product Part Type Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function	Σ	0..*	CodeableConcept	The function of this component within the item e.g. delivers active ingredient, masks taste
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Product Part Function Description
amount	Σ	0..*	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
WghtlDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
constituent	SΣC	1..*	BackboneElement	A reference to a constituent of the manufactured item as a whole, linked here so that its component location within the item can be indicated. This not where the item's ingredient are primarily stated (for which see Ingredient.for or ManufacturedItemDefinition.ingredient) cmc-ingredient-functions: If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
ConstituentPercent	S	1..1	decimal	Constituent Content Percent URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
amount	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
OptionalDenom	S	0..1	Quantity	Product Part Total Weight Numeric Denominator | Product Part Ingredient Amount Numeric Denominator URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM
system	ΣC	0..1	uri	System that defines coded unit form
code	SΣC	1..1	code	Coded form of the unit Binding: Units Of Measure Terminology (required)
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Binding: Ingredient Location Terminology (required)
text	SΣ	0..1	string	Plain text representation of the concept
Slices for function	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:coding
function:All Slices				Content/Rules for all slices
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
function:Category	SΣ	1..1	CodeableConcept	Product Part Ingredient Component Function Category
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Drug Product Component Function Category Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
function:Function	SΣ	0..1	CodeableConcept	Product Part Ingredient Function
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Excipient Function Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component
Slices for property	SΣ	3..*	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type
property:PPiD	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiD
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Product Part Role Binding: Relationship Types Terminology (required)
text	SΣ	1..1	string	Product Part Identifier
property:PPiDref	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: PPiDref
display		1..1	string	Representation defined by the system Fixed Value: Product Part Identifier Reference
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Identifier Reference
property:RelsProf	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsProf
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Profile
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Profile
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Profile Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:RelsMech	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RelsMech
display		1..1	string	Representation defined by the system Fixed Value: Product Part Release Mechanism
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Product Part Release Mechanism
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Release Mechanism Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:CoatPurpose	SΣ	0..*	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: CoatPurpose
display		1..1	string	Representation defined by the system Fixed Value: Coating Product Part Purpose
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	Coating Product Part Purpose
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: Coating Purpose Terminology (required)
text	Σ	0..1	string	Plain text representation of the concept
property:Color	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: Color
display		1..1	string	Representation defined by the system Fixed Value: Product Part Color Description
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	CodeableConcept	A value for the characteristic
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Product Part Color Description
property:ContPercent	SΣ	1..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ContPercent
display		1..1	string	Representation defined by the system Fixed Value: Product Part Content Percent
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	SΣ	1..1	Quantity	Product Part Content Percent
property:AddInfo	SΣ	0..1	BackboneElement	General characteristics of this component
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: AddInfo
display		1..1	string	Representation defined by the system Fixed Value: Product Part Additional Information
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	markdown	Product Part Additional Information
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
ManufacturedItemDefinition.meta.security	extensible	AllSecurityLabels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ManufacturedItemDefinition.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ManufacturedItemDefinition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm	example	ManufacturedDoseForm http://hl7.org/fhir/ValueSet/manufactured-dose-form from the FHIR Standard
ManufacturedItemDefinition.manufacturedDoseForm.coding	required	PqcmcManufacturedDoseFormTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-manufactured-dose-form-terminology from this IG
ManufacturedItemDefinition.unitOfPresentation	example	UnitOfPresentation http://hl7.org/fhir/ValueSet/unit-of-presentation from the FHIR Standard
ManufacturedItemDefinition.ingredient	example	SNOMEDCTSubstanceCodes http://hl7.org/fhir/ValueSet/substance-codes from the FHIR Standard
ManufacturedItemDefinition.property.type	example	ProductCharacteristic http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.property:OvrRelsProf.type	required	Pattern: OvrRelsProf("Product Overall Release Profile") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsProf.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.property:OvrRelsMech.type	required	Pattern: OvrRelsMech("Product Overall Release Mechanism") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:OvrRelsMech.value[x]:valueCodeableConcept.coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.property:CoatInd.type	required	Pattern: CoatInd("Coating Indicator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.type	required	Pattern: TabLayCnt("Tablet Layer Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:LayCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:BeaTypCnt.type	required	Pattern: BeaTypCnt("Tablet Bead Type Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:BeaTypCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:CapClass.type	required	Pattern: CapClass("Capsule Classification Category") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapClass.value[x]:valueCodeableConcept.coding	required	PqcmcCapsuleClassificationCategory http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category from this IG
ManufacturedItemDefinition.property:CapConCnt.type	required	Pattern: CapConCnt("Capsule Constituent Count") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:CapConCnt.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:Schematic.type	required	Pattern: Schematic("Product Schematic") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.type	required	Pattern: WgtTyp("Product Weight Type") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:WgtTyp.value[x]:valueCodeableConcept.coding	required	PqcmcStrengthTypeTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-type-terminology from this IG
ManufacturedItemDefinition.property:TotWgtNum.type	required	Pattern: TotWgtNum("Product Total Weight Numeric Numerator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtNum.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtNum.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtDen.type	required	Pattern: TotWgtDen("Product Total Weight Numeric Denominator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtDen.value[x].comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.property:TotWgtDen.value[x].code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.property:TotWgtTxt.type	required	Pattern: TotWgtTxt("Total Weight Textual") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.type	required	Pattern: TotWgtOper("Total Weight Operator") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:TotWgtOper.value[x]:valueCodeableConcept	required	PqcmcStrengthOperatorTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-strength-operator-terminology from this IG
ManufacturedItemDefinition.property:QualStd.type	required	Pattern: QualStd("Quality Standard") http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-characteristic from this IG
ManufacturedItemDefinition.property:QualStd.value[x]:valueCodeableConcept	required	PqcmcQualityBenchmarkTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology from this IG
ManufacturedItemDefinition.component.type.coding	required	PqcmcProductPartType http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-type from this IG
ManufacturedItemDefinition.component.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.amount.comparator	required	QuantityComparator http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0 from the FHIR Standard
ManufacturedItemDefinition.component.constituent.amount.code	required	PqcmcUnitsMeasureTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-units-of-measure-terminology from this IG
ManufacturedItemDefinition.component.constituent.location.coding	required	PqcmcProductPartIngredientPhysicalLocation http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-product-part-ingredient-physical-location from this IG
ManufacturedItemDefinition.component.constituent.function:Category.coding	required	PqcmcDrugProductComponentFunctionCategoryTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-drug-product-component-function-category-terminology from this IG
ManufacturedItemDefinition.component.constituent.function:Function.coding	required	PqcmcExcipientFunctionTerminology http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-excipient-function-terminology from this IG
ManufacturedItemDefinition.component.property:PPiD.type	example	Pattern: PPiD("Product Part Identifier") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:PPiD.value[x].coding	required	CmcRelationshipTypesVS (a valid code from Relationship Types Codes) http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-relationship-types-vs from this IG
ManufacturedItemDefinition.component.property:PPiDref.type	example	Pattern: PPiDref("Product Part Identifier Reference") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.type	example	Pattern: RelsProf("Product Part Release Profile") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsProf.value[x].coding	required	PqcmcReleaseProfile http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-profile from this IG
ManufacturedItemDefinition.component.property:RelsMech.type	example	Pattern: RelsMech("Product Part Release Mechanism") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:RelsMech.value[x].coding	required	PqcmcReleaseMechanism http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-release-mechanism from this IG
ManufacturedItemDefinition.component.property:CoatPurpose.type	example	Pattern: CoatPurpose("Coating Product Part Purpose") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:CoatPurpose.value[x].coding	required	PqcmcCoatingPurpose http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-coating-purpose from this IG
ManufacturedItemDefinition.component.property:Color.type	example	Pattern: Color("Product Part Color Description") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:ContPercent.type	example	Pattern: ContPercent("Product Part Content Percent") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard
ManufacturedItemDefinition.component.property:AddInfo.type	example	Pattern: AddInfo("Product Part Additional Information") http://hl7.org/fhir/ValueSet/product-characteristic-codes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmc-arbitrary-unit-text-required	error	ManufacturedItemDefinition	BR – Product Total Weight Textual - If the UOM is UCUM Arbitrary Unit [arb'U], units must be described in Weight Textual : property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'TotWgtNum' or code = 'TotWgtDen' ) ) and value.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C75765') ).exists() implies property.where( type.coding.exists( code = 'TotWgtTxt' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' ) ).exists()
cmc-capsule-classification-required	error	ManufacturedItemDefinition	when the the dosage form is 'capsule' and a 'capsule shell' part exists, a capsule shell part classification is mandatory : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433' ) and component.type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C203897' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapClass' ) ).exists()
cmc-capsule-count-required	error	ManufacturedItemDefinition	Capsule constituent count is required when the dosage form is 'Capsule' : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154433') implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CapConCnt')).exists()
cmc-coating-indication-required	error	ManufacturedItemDefinition	Coating indication is required when the dosage form is a tablet, lozenge or capsule : manufacturedDoseForm.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and ( code = 'C154605' or code = 'C154433' or code = 'C154554' )) implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'CoatInd')).exists()
cmc-ingredient-functions	error	ManufacturedItemDefinition.component.constituent	If Drug Product Component constituent Function Category is Active Ingredient or Adjuvant THEN Drug Product Component constituent Function is not applicable. If Drug Product Component Function Category constituent is Inactive Ingredient (excipient) THEN Drug Product Component Function must be from the value list. : function.coding.where(code = 'C42637' and system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy').exists() implies function.coding.code.count() = 2
cmc-ppidref-required	error	ManufacturedItemDefinition.component	A PPiDref is required when the PPiD is designated a child. : property.where( type.coding.exists(system = '' and code = 'PPiD') and value.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-relationship-types' and code = 'child') ).exists() implies property.where(type.coding.exists(system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-product-characteristic' and code = 'PPiDref')).exists()
cmc-tablet-bead-count-required	error	ManufacturedItemDefinition	Tablet bead count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'BeaTypCnt' ) ).exists()
cmc-tablet-layer-count-required	error	ManufacturedItemDefinition	Tablet layer count is required when the dosage form is a tablet : manufacturedDoseForm.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'C154605' ) implies property.where( type.coding.exists( system = 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy' and code = 'TabLayCnt' ) ).exists()
dom-2	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ManufacturedItemDefinition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ManufacturedItemDefinition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ManufacturedItemDefinition	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ManufacturedItemDefinition

Summary

Mandatory: 33 elements(24 nested mandatory elements)
Must-Support: 96 elements

Structures

This structure refers to these other structures:

• Drug Product Component (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/optional-denominator
• http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/content-percent

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ManufacturedItemDefinition.property (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.property.value[x]
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.constituent.function (Closed)
• The element 1 is sliced based on the value of ManufacturedItemDefinition.component.property (Closed)