description: Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.
package_name: hl7.fhir.us.pq
derivation: constraint
name: ExcipientRaw
type: SubstanceDefinition
elements:
  identifier: {short: optional user designated identifier, index: 0}
  classification:
    short: Substance Type
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification'}
    mustSupport: true
    index: 1
  grade:
    short: Quality Standard
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology'}
    index: 2
  manufacturer:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 3
  supplier:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 4
  code:
    mustSupport: true
    index: 5
    slicing:
      rules: open
      discriminator:
      - {path: code.coding.system, type: value}
      min: 1
      slices:
        unii:
          match:
            code:
              coding: {system: 'http://fdasis.nlm.nih.gov'}
          schema:
            short: UNII
            index: 6
            elements:
              code:
                mustSupport: true
                index: 7
                elements:
                  coding:
                    mustSupport: true
                    index: 8
                    elements:
                      system:
                        pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                        mustSupport: true
                        index: 9
                    required: [system]
                required: [coding]
            required: [code]
        uniProt:
          match:
            code:
              coding: {system: 'https://www.uniprot.org'}
          schema:
            short: UniProt ID
            index: 10
            elements:
              code:
                mustSupport: true
                index: 11
                elements:
                  coding:
                    mustSupport: true
                    index: 12
                    elements:
                      system:
                        pattern: {type: Uri, value: 'https://www.uniprot.org'}
                        mustSupport: true
                        index: 13
                    required: [system]
                required: [coding]
            required: [code]
  name:
    short: Substance Name
    constraint:
      cmc-name-preferred: {human: 'Name.preferred: at most one = true', source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient', severity: error, expression: select(preferred = true).count() < 2}
    mustSupport: true
    index: 14
    elements:
      type:
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type'}
        index: 15
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 16}
    slicing:
      rules: closed
      description: Slice based on value pattern
      discriminator:
      - {path: type, type: value}
      min: 1
      slices:
        sub:
          match:
            type:
              coding:
              - {code: C97054, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: Generic Name}
          schema:
            mustSupport: true
            index: 17
            elements:
              name: {short: Generic Name, mustSupport: true, index: 18}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C97054, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: Generic Name}
                index: 19
              preferred: {mustSupport: true, index: 20}
            required: [type]
        gsrs:
          match:
            type:
              coding:
              - {code: C203355, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: GSRS Preferred Term}
          schema:
            mustSupport: true
            index: 21
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 22}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C203355, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: GSRS Preferred Term}
                index: 23
              preferred: {mustSupport: true, index: 24}
            required: [type]
        isbt:
          match:
            type:
              coding:
              - {code: C95517, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: ISBT-128 DIN}
          schema:
            mustSupport: true
            index: 25
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 26}
              type:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: C95517, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl', display: ISBT-128 DIN}
                index: 27
              preferred: {mustSupport: true, index: 28}
            required: [type]
  sourceMaterial:
    mustSupport: true
    index: 29
    elements:
      type:
        short: Source Type
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology'}
        index: 30
      genus: {type: CodeableConcept, short: Source Organism Genus, mustSupport: true, index: 31}
      species: {type: CodeableConcept, short: Source Organism Species, mustSupport: true, index: 32}
      part: {type: CodeableConcept, short: Source Organism Part, mustSupport: true, index: 33}
      countryOfOrigin:
        short: Source Organism Country of Origin
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect'}
        mustSupport: true
        index: 34
    required: [type]
package_version: cmc-fda-2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
version: 2.0.0-ballot
required: [grade, name, sourceMaterial, code, classification]