description: The fields needed to Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: EctdCompositionSP4151
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: SP4151, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Quality Specification}
    index: 3
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization']
    index: 4
  title: {mustSupport: true, index: 5}
  section:
    mustSupport: true
    index: 6
    elements:
      title: {mustSupport: true, index: 7}
      code:
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs'}
        mustSupport: true
        index: 8
      entry: {mustSupport: true, index: 9}
    required: [title, code]
    slicing:
      rules: closed
      description: 'There is only one section in the profile. The slice the code must correpond to the subject of the Quality Specification profile: RoutineDrugProduct or Routine Api or Excipient'
      discriminator:
      - {path: code, type: value}
      min: 1
      max: 1
      slices:
        DrugProduct:
          match:
            code:
              coding:
              - {code: 32P51, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Product Specification}
          schema:
            mustSupport: true
            index: 10
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 32P51, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Product Specification}
                index: 11
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification']
                index: 12
            required: [entry]
        Api:
          match:
            code:
              coding:
              - {code: 32S41, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Substance Specification}
          schema:
            mustSupport: true
            index: 13
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 32S41, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Substance Specification}
                index: 14
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification']
                index: 15
            required: [entry]
        Excipient:
          match:
            code:
              coding:
              - {code: 32P40, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Product Control of Excipients}
          schema:
            mustSupport: true
            index: 16
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 32P40, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types', display: Product Control of Excipients}
                index: 17
              entry:
                type: Reference
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification']
                index: 18
            required: [entry]
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 1.0.0-ballot
required: [section]