Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 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/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension | Version: 0.1.20 | |||
| Draft as of 2024-03-04 | Computable Name: ContainerClosureExtension | |||
The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.
Context of Use
This extension may be used on the following element(s):
Usage info
Usage:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
Summary
Complex Extension: The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension | 0..* | Extension | Container Closure System Information | |
  extension | 3..* | Extension | Extension | |
  extension:containerType | S | 1..1 | Extension | Extension |
  extension | 0..0 | |||
| url | 1..1 | uri | "containerType" | |
  value[x] | 1..1 | CodeableConcept | Container Type Binding: Container Type Terminology (required) | |
| extension:closureType | S | 1..1 | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "closureType" | |
| value[x] | 1..1 | CodeableConcept | Closure Type Binding: Closure Type Terminology (required) | |
| extension:description | S | 1..1 | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "description" | |
 value[x] | 1..1 | markdown | Container Closure System Description | |
| extension:depiction | S | 0..* | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "depiction" | |
 value[x] | 1..1 | Reference(Document Reference Attachment) | Value of extension | |
| url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension" | |
 value[x] | 0..0 | |||
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension | 0..* | Extension | Container Closure System Information | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| Slices for extension | 3..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:containerType | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "containerType" | |
| value[x] | 1..1 | CodeableConcept | Container Type Binding: Container Type Terminology (required) | |
| extension:closureType | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "closureType" | |
| value[x] | 1..1 | CodeableConcept | Closure Type Binding: Closure Type Terminology (required) | |
| extension:description | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "description" | |
| value[x] | 1..1 | markdown | Container Closure System Description | |
| extension:depiction | S | 0..* | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "depiction" | |
| value[x] | 1..1 | Reference(Document Reference Attachment) | Value of extension | |
| url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension" | |
| Documentation for this format | ||||
This structure is derived from Extension
Summary
Complex Extension: The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials.
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension | 0..* | Extension | Container Closure System Information | |
| extension | 3..* | Extension | Extension | |
| extension:containerType | S | 1..1 | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "containerType" | |
| value[x] | 1..1 | CodeableConcept | Container Type Binding: Container Type Terminology (required) | |
| extension:closureType | S | 1..1 | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "closureType" | |
| value[x] | 1..1 | CodeableConcept | Closure Type Binding: Closure Type Terminology (required) | |
| extension:description | S | 1..1 | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "description" | |
| value[x] | 1..1 | markdown | Container Closure System Description | |
| extension:depiction | S | 0..* | Extension | Extension |
| extension | 0..0 | |||
| url | 1..1 | uri | "depiction" | |
| value[x] | 1..1 | Reference(Document Reference Attachment) | Value of extension | |
| url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension" | |
| value[x] | 0..0 | |||
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension | 0..* | Extension | Container Closure System Information | |
| id | 0..1 | id | Unique id for inter-element referencing | |
| Slices for extension | 3..* | Extension | Extension Slice: Unordered, Open by value:url | |
| extension:containerType | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "containerType" | |
| value[x] | 1..1 | CodeableConcept | Container Type Binding: Container Type Terminology (required) | |
| extension:closureType | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "closureType" | |
| value[x] | 1..1 | CodeableConcept | Closure Type Binding: Closure Type Terminology (required) | |
| extension:description | S | 1..1 | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "description" | |
| value[x] | 1..1 | markdown | Container Closure System Description | |
| extension:depiction | S | 0..* | Extension | Extension |
| id | 0..1 | id | Unique id for inter-element referencing | |
| extension | 0..0 | |||
| url | 1..1 | uri | "depiction" | |
| value[x] | 1..1 | Reference(Document Reference Attachment) | Value of extension | |
| url | 1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension" | |
| Documentation for this format | ||||
Other representations of profile: CSV, Excel, Schematron
| Path | Conformance | ValueSet | URI |
| Extension.extension:containerType.value[x] | required | PqcmcContainerTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminologyfrom this IG | |
| Extension.extension:closureType.value[x] | required | PqcmcClosureTypeTerminologyhttp://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminologyfrom this IG |
| 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() |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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