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

Data Type Profile: Literal Coded Reference ( Abstract )

abstract profile to ensure the reference portion of a codeable reference is used, and that the reference is a literal reference to some resource in a bundle

Usage:

• Use this DataType Constraint: Drug Product Component, Drug Product Batch Formula Ingredient, Drug Product Description, Drug Product Impurities... Show 2 more, Drug Product Batch Formula and Manufactured Drug Product

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 CodeableReference

Name	Flags	Card.	Type	Description & Constraints
CodeableReference			CodeableReference	This is an abstractprofile.
reference	S	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
CodeableReference		0..*	CodeableReference	This is an abstractprofile. Reference to a resource or a concept
reference	SΣ	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Name	Flags	Card.	Type	Description & Constraints
CodeableReference		0..*	CodeableReference	This is an abstractprofile. Reference to a resource or a concept
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)
reference	SΣ	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
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 CodeableReference

Summary

Mandatory: 1 element
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)

Differential View

This structure is derived from CodeableReference

Name	Flags	Card.	Type	Description & Constraints
CodeableReference			CodeableReference	This is an abstractprofile.
reference	S	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
CodeableReference		0..*	CodeableReference	This is an abstractprofile. Reference to a resource or a concept
reference	SΣ	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
CodeableReference		0..*	CodeableReference	This is an abstractprofile. Reference to a resource or a concept
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)
reference	SΣ	1..1	LiteralReference() {b}	Reference to a resource (by instance)
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
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 CodeableReference

Summary

Mandatory: 1 element
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)

Other representations of profile: CSV, Excel, Schematron