Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition
copyright
date	2024-04-08T17:51:06+00:00	2024-12-11T13:47:08+00:00	Values Differ
description	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.
experimental
fhirVersion	5.0.0
jurisdiction
jurisdiction[0]	urn:iso:std:iso:3166#US
kind	resource
name	FinishedProduct
publisher	HL7 International / Biomedical Research and Regulation
purpose
status	active
title	Manufactured Drug Product
type	ManufacturedItemDefinition
url	http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	R Type	R Description & Constraints	Comments
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	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 cmc-component-id-ref: If a PPiD ref is present, it must reference the PPiD of another component. It cannot reference itself
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
versionId	Σ	0..1	id	Version specific identifier					Removed this element
lastUpdated	Σ	0..1	instant	When the resource version last changed					Removed this element
source	Σ	0..1	uri	Identifies where the resource comes from					Removed this element
profile	SΣ	1..1	canonical(StructureDefinition)	Profiles this resource claims to conform to					Removed this element
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System.					Removed this element
tag	Σ	0..*	Coding	Tags applied to this resource Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".					Removed this element
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..1	Identifier	Unique identifier	SΣ	0..1	Identifier	Unique identifier
status	?!SΣ	1..1	code	draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact.	?!SΣ	1..1	code	draft | active | retired | unknown Binding: ?? (required): The lifecycle status of an artifact.
name	SΣ	0..1	string	Product Proprietary Name | Product Non-proprietary 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: ?? (example): Dose form for a medication, in the form suitable for administering to the patient, after mixing, where necessary.	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ?? (required)
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: ?? (required)					Removed this element
text	Σ	0..1	string	Plain text representation of the concept					Removed this element
unitOfPresentation	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: ?? (example): The presentation type in which an administrable medicinal product is given to a patient.	Σ	0..1	CodeableConcept	The “real-world” units in which the quantity of the item is described Binding: ?? (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	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	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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Σ	0..*	CodeableConcept	The ingredients of this manufactured item. Only needed if these are not specified by incoming references from the Ingredient resource Binding: ?? (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	SΣ	6..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type.text	Element minimum cardinalities differ: '5' vs '6'
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Elements differ in definition for mustSupport: 'false' vs 'true'
id						0..1	id	Unique id for inter-element referencing	Added this element
Slices for extension						0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Added this element
coding					Σ	0..*	Coding	Code defined by a terminology system	Added this element
text					SΣ	1..1	string	Plain text representation of the concept	Added this element
value[x]	Σ	0..1	CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)	A value for the characteristic	Σ	0..1	CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)	A value for the characteristic
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.	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-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
type	SΣ	1..1	CodeableConcept	Product Part Type	SΣ	1..1	CodeableConcept	Product Part Type
id		0..1	id	Unique id for inter-element referencing		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		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system Binding: ?? (required)	Σ	0..*	Coding	Code defined by a terminology system Binding: ?? (required)
text	Σ	0..1	string	Plain text representation of the concept	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	S	0..*	??	Product Part Function Description	Elements differ in definition for mustSupport: 'false' vs 'true'
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
coding	Σ	0..*	Coding	Code defined by a terminology system					Removed this element
text	SΣ	0..1	string	Product Part Function Description					Removed this element
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)	SΣ	0..2	Quantity	The measurable amount of total quantity of all substances in the component, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code	Elements differ in definition for mustSupport: 'false' vs 'true' Element maximum cardinalities differ: '2147483647' vs '2'
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
value	SΣ	1..1	decimal	Product Part Total Weight Numeric Numerator					Removed this element
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented.					Removed this element
unit	SΣ	1..1	string	Product Part Total Weight Numeric Numerator UOM					Removed this element
system	ΣC	0..1	uri	System that defines coded unit form					Removed this element
code	SΣC	1..1	code	Coded form of the unit Binding: ?? (required)					Removed this element
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.	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category 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. cmc-amount-ratio-or-quantity: The amount ratio extension and an amount with a non-percentage unit are mutually exclusive
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url		0..*	Extension	Extension Slice: Unordered, Open by value:url	Element minimum cardinalities differ: '1' vs '0'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
amount	SΣ	1..1	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume)	SΣ	1..2	Quantity	The measurable amount of the substance, expressable in different ways (e.g. by mass or volume) Slice: Unordered, Open by value:code	Element maximum cardinalities differ: '1' vs '2'
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
value	SΣ	1..1	decimal	Product Part Ingredient Amount Numeric Numerator					Removed this element
comparator	?!Σ	0..1	code	< | <= | >= | > | ad - how to understand the value Binding: ?? (required): How the Quantity should be understood and represented.					Removed this element
unit	SΣ	1..1	string	Product Part Ingredient Amount Numeric Numerator UOM					Removed this element
system	ΣC	0..1	uri	System that defines coded unit form					Removed this element
code	SΣC	1..1	code	Coded form of the unit Binding: ?? (required)					Removed this element
location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location	SΣ	0..*	CodeableConcept	Product Part Ingredient Physical Location
id		0..1	id	Unique id for inter-element referencing		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		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: ?? (required)	SΣ	1..1	Coding	Code defined by a terminology system Binding: ?? (required)
text	SΣ	0..1	string	Plain text representation of the concept	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	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
id		0..1	id	Unique id for inter-element referencing					Removed this element
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url					Removed this element
coding	SΣ	1..1	Coding	Code defined by a terminology system					Removed this element
text	Σ	0..1	string	Plain text representation of the concept					Removed this element
hasIngredient	SΣ	1..1	CodeableReference(Drug Product Component)	The ingredient that is the constituent of the given component	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept
Slices for property	SΣ	3..*	See property (ManufacturedItemDefinition)	General characteristics of this component Slice: Unordered, Closed by value:type	SΣ	2..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text	Element minimum cardinalities differ: '3' vs '2' Type Mismatch: vs BackboneElement
id						0..1	string	Unique id for inter-element referencing	Added this element
extension						0..*	Extension	Additional content defined by implementations	Added this element
modifierExtension					?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Added this element
type					SΣ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Added this element
value[x]					Σ	0..1	CodeableConcept, Quantity, date, boolean, markdown, Attachment, Reference(Binary)	A value for the characteristic	Added this element
component	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from
Documentation for this format