Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions

Extension: Container Closure

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-container-closure-extension Version: 1.0.0-ballot
Active as of 2024-04-08 Computable Name: ContainerClosureExtension
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.16

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):

  • Element ID MedicinalProductDefinition
  • Element ID SubstanceDefinition

Usage info

Usage:

Formal Views of Extension Content

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.

  • containerType: CodeableConcept: An Extension
  • closureType: CodeableConcept: An Extension
  • description: markdown: An Extension
  • depiction: Reference: An Extension

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 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

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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"

doco 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.

  • containerType: CodeableConcept: An Extension
  • closureType: CodeableConcept: An Extension
  • description: markdown: An Extension
  • depiction: Reference: An Extension

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 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

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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)
.... 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"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.extension:containerType.value[x]requiredPqcmcContainerTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-container-type-terminology
from this IG
Extension.extension:closureType.value[x]requiredPqcmcClosureTypeTerminology
http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-closure-type-terminology
from this IG

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()