description: The fields needed to represent the Product Characterisation of Impurities in a to be included under the eCTD. References Sponsor Organization and Product Characterisation of Impurities
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: EctdComposition32P55
type: Composition
elements:
  identifier: {mustSupport: true, index: 0}
  status:
    pattern: {type: Code, value: final}
    index: 1
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: 32P55, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Product Characterisation of Impurities}
    index: 2
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 3
  section:
    mustSupport: true
    index: 4
    elements:
      code: {mustSupport: true, index: 5}
    required: [code]
    slicing:
      rules: open
      ordered: false
      description: Slice on the ICH Section code. only one slice is defined but is left open for other sections that won't be parsed
      discriminator:
      - {path: code, type: value}
      min: 1
      slices:
        Characterisation:
          match:
            code:
              coding:
              - {code: ich_3.2.p.5.5, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Characterisation of Impurities}
          schema:
            mustSupport: true
            _required: true
            index: 6
            elements:
              title: {mustSupport: true, index: 7}
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: ich_3.2.p.5.5, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Characterisation of Impurities}
                index: 8
              entry:
                type: Reference
                mustSupport: true
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-with-impurities']
                index: 9
            required: [entry, title]
package_version: 2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p55
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 2.0.0-ballot
required: [section]