description: The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: EctdComposition32S23
type: Composition
elements:
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
    required: [profile]
  identifier: {mustSupport: true, index: 1}
  status:
    pattern: {type: Code, value: final}
    index: 2
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: 32S23, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Substance Control of Materials}
    index: 3
  subject:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance']
    index: 4
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization']
    index: 5
  title: {mustSupport: true, index: 6}
  section:
    mustSupport: true
    index: 7
    elements:
      code:
        pattern:
          type: CodeableConcept
          value:
            coding:
            - {code: 32S231, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Raw Material Specification}
        index: 8
      entry:
        type: Reference
        mustSupport: true
        refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification']
        index: 9
    required: [entry]
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 1.0.0-ballot
required: [section, subject]