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 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: Text Only Codeable Concept ( Abstract )

An abstract profile for the common scenario where only the text field is used and is required. Doesn't stop the coding portion from being used but it will not be parsed

Usages:

• Use this DataType Profile: Component Substance, Drug Substance Impurity, Drug Substance, Substance General Information... Show 5 more, Excipient Drug Substance, Polymorphic Form, Drug Product Batch Formula, Manufactured Drug Product and Quality Specification

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept		0..*	CodeableConcept	This is an abstract profile. Concept - reference to a terminology or just text
text	SΣ	1..1	string	Plain text representation of the concept
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())

This structure is derived from CodeableConcept

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept			CodeableConcept	This is an abstract profile.
text	S	1..1	string	Plain text representation of the concept
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept		0..*	CodeableConcept	This is an abstract profile. Concept - reference to a terminology or just text
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	Plain text representation of the concept
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 CodeableConcept

Summary

Mandatory: 1 element
Must-Support: 1 element

Maturity: 2

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept		0..*	CodeableConcept	This is an abstract profile. Concept - reference to a terminology or just text
text	SΣ	1..1	string	Plain text representation of the concept
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())

Differential View

This structure is derived from CodeableConcept

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept			CodeableConcept	This is an abstract profile.
text	S	1..1	string	Plain text representation of the concept
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
CodeableConcept		0..*	CodeableConcept	This is an abstract profile. Concept - reference to a terminology or just text
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	Plain text representation of the concept
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 CodeableConcept

Summary

Mandatory: 1 element
Must-Support: 1 element

Maturity: 2

Other representations of profile: CSV, Excel, Schematron