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	2024-12-12T19:00:52+00:00	2025-07-08T07:43:10+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	2.0.0-ballot	2.0.0	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 Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref	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 Constraints: cmc-capsule-count-required, cmc-arbitrary-unit-text-required, cmc-coating-indication-required, cmc-tablet-layer-count-required, cmc-tablet-bead-count-required, cmc-capsule-classification-required, cmc-component-id-ref
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
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		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language Additional Bindings Purpose ?? Starter
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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: ?? (required)	Σ	1..1	CodeableConcept	Dose form as manufactured (before any necessary transformation) Binding: ?? (required)
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	6..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type.text	SΣ	6..*	BackboneElement	General characteristics of this item Slice: Unordered, Closed by value:type.text
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	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.	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.
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	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Plain text representation of the concept	SΣ	1..1	string	Plain text representation of the concept
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 Constraints: cmc-amount-ratio-or-quantity	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 Constraints: cmc-amount-ratio-or-quantity
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
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url	?!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	S	0..*	??	Product Part Function Description	SΣ	0..*	??	Product Part Function Description
Slices for amount	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	SΣ	1..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	Element minimum cardinalities differ: '0' vs '1'
constituent	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity	SΣC	1..*	BackboneElement	Product Part Ingredient Component Function Category Constraints: cmc-ingredient-functions, cmc-amount-ratio-or-quantity
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url		0..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for modifierExtension	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url	?!Σ	0..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for amount	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	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
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:$this	SΣ	1..2	CodeableConcept	The function of this constituent within the component e.g. binder Slice: Unordered, Closed by value:$this
hasIngredient	S	1..1	LiteralCodeableReference(Drug Product Component) {b}	Reference to a resource or a concept	SΣ	1..1	LiteralCodeableReference(Drug Product Component) {b}	The ingredient that is the constituent of the given component
Slices for property	SΣ	2..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text	SΣ	2..*	BackboneElement	General characteristics of this component Slice: Unordered, Closed by value:type.text
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	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.	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.
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	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	1..1	string	Plain text representation of the concept	SΣ	1..1	string	Plain text representation of the concept
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	SΣ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from	Σ	0..*	See component (ManufacturedItemDefinition)	A component that this component contains or is made from	Elements differ in definition for mustSupport: 'true' vs 'false'
Documentation for this format