Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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

## Data Type Profile: Literal Coded Reference ( Abstract )

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-codeable-reference | Version: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | Computable Name: LiteralCodeableReference
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.62

An 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

Usages:

- Use this DataType Profile: 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.

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

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  | 0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept
reference | S Σ | 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()) |

This structure is derived from CodeableReference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  |  | CodeableReference | This is an abstract profile.
reference | S | 1..1 | LiteralReference() {b} | Reference to a resource (by instance)
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  | 0..* | CodeableReference | This is an abstract profile. 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 | S Σ | 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)

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  | 0..* | CodeableReference | This is an abstract profile. Reference to a resource or a concept
reference | S Σ | 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()) |

Differential View

This structure is derived from CodeableReference

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  |  | CodeableReference | This is an abstract profile.
reference | S | 1..1 | LiteralReference() {b} | Reference to a resource (by instance)
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
CodeableReference |  | 0..* | CodeableReference | This is an abstract profile. 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 | S Σ | 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)

Maturity: 2

Other representations of profile: CSV, Excel, Schematron