Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

• Content
• Detailed Descriptions
• XML
• JSON

Resource Profile: eCTD Specification Composition

The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.

Usage:

• Use this Resource Profile: CMC eCTD SP4151 Document

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 Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
identifier	S	0..1	Identifier	Version-independent identifier for the Composition
status		1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final
type	S	1..1	CodeableConcept	Kind of composition (LOINC if possible)
author	S	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
section	S	1..1	BackboneElement	Composition is broken into sections
title	S	1..1	string	Label for section (e.g. for ToC)
entry	S	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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	Version-independent identifier for the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
date	Σ	1..1	dateTime	Composition editing time
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
section	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title	S	1..1	string	Label for section (e.g. for ToC)
entry	SC	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	SΣ	0..1	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
section	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title	S	1..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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 Composition

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Quality Specification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification)

Differential View

This structure is derived from Composition

Name	Flags	Card.	Type	Description & Constraints
Composition			Composition
identifier	S	0..1	Identifier	Version-independent identifier for the Composition
status		1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Required Pattern: final
type	S	1..1	CodeableConcept	Kind of composition (LOINC if possible)
author	S	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	S	1..1	string	Human Readable name/title
section	S	1..1	BackboneElement	Composition is broken into sections
title	S	1..1	string	Label for section (e.g. for ToC)
entry	S	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
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	Version-independent identifier for the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
date	Σ	1..1	dateTime	Composition editing time
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
title	SΣ	1..1	string	Human Readable name/title
section	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
title	S	1..1	string	Label for section (e.g. for ToC)
entry	SC	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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
Composition		0..*	Composition	A set of resources composed into a single coherent clinical statement with clinical attestation
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
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
url	Σ	0..1	uri	Canonical identifier for this Composition, represented as a URI (globally unique)
identifier	SΣ	0..1	Identifier	Version-independent identifier for the Composition
version	Σ	0..1	string	An explicitly assigned identifer of a variation of the content in the Composition
status	?!Σ	1..1	code	registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: CompositionStatus (required): The workflow/clinical status of the composition. Required Pattern: final
type	SΣ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
category	Σ	0..*	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
subject	Σ	0..*	Reference(Resource)	Who and/or what the composition is about
encounter	Σ	0..1	Reference(Encounter)	Context of the Composition
date	Σ	1..1	dateTime	Composition editing time
useContext	Σ	0..*	UsageContext	The context that the content is intended to support
author	SΣ	1..1	LiteralReference(Basic Organization) {b}	Who and/or what authored the composition
name	Σ	0..1	string	Name for this Composition (computer friendly)
title	SΣ	1..1	string	Human Readable name/title
note		0..*	Annotation	For any additional notes
attester		0..*	BackboneElement	Attests to accuracy of composition
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
mode		1..1	CodeableConcept	personal | professional | legal | official Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.
time		0..1	dateTime	When the composition was attested
party		0..1	Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization)	Who attested the composition
custodian	Σ	0..1	Reference(Organization)	Organization which maintains the composition
relatesTo		0..*	RelatedArtifact	Relationships to other compositions/documents
event	Σ	0..*	BackboneElement	The clinical service(s) being documented
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
period	Σ	0..1	Period	The period covered by the documentation
detail	Σ	0..*	CodeableReference(Resource)	The event(s) being documented, as code(s), reference(s), or both Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.
section	SC	1..1	BackboneElement	Composition is broken into sections cmp-1: A section must contain at least one of text, entries, or sub-sections cmp-2: A section can only have an emptyReason if it is empty
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
title	S	1..1	string	Label for section (e.g. for ToC)
code		0..1	CodeableConcept	Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.
author		0..*	Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization)	Who and/or what authored the section
focus		0..1	Reference(Resource)	Who/what the section is about, when it is not about the subject of composition
text	C	0..1	Narrative	Text summary of the section, for human interpretation
orderedBy		0..1	CodeableConcept	Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry	SC	0..*	LiteralReference(Quality Specification) {b}	A reference to data that supports this section
emptyReason	C	0..1	CodeableConcept	Why the section is empty Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.
section		0..*	See section (Composition)	Nested Section
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Composition.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
Composition.status	required	Pattern: final http://hl7.org/fhir/ValueSet/composition-status|5.0.0 from the FHIR Standard
Composition.type	preferred	FHIRDocumentTypeCodes http://hl7.org/fhir/ValueSet/doc-typecodes from the FHIR Standard
Composition.category	example	ReferencedItemCategoryValueSet http://hl7.org/fhir/ValueSet/referenced-item-category from the FHIR Standard
Composition.attester.mode	preferred	CompositionAttestationMode http://hl7.org/fhir/ValueSet/composition-attestation-mode from the FHIR Standard
Composition.event.detail	example	ActCode http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.code	example	DocumentSectionCodes http://hl7.org/fhir/ValueSet/doc-section-codes from the FHIR Standard
Composition.section.orderedBy	preferred	ListOrderCodes http://hl7.org/fhir/ValueSet/list-order from the FHIR Standard
Composition.section.emptyReason	preferred	ListEmptyReasons http://hl7.org/fhir/ValueSet/list-empty-reason from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
cmp-1	error	Composition.section	A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists()
cmp-2	error	Composition.section	A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty()
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Composition	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	Composition	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	Composition	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Composition	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 Composition

Summary

Mandatory: 2 elements
Must-Support: 7 elements

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
• Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
• Quality Specification (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification)

Other representations of profile: CSV, Excel, Schematron