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-cmc-fda
derivation: constraint
name: ExcipientRaw
type: SubstanceDefinition
elements:
  supplier:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization']
    index: 6
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
    required: [profile]
  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:
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 15}
    slicing:
      rules: closed
      description: Slice based on value pattern
      discriminator:
      - {path: type.coding, type: value}
      min: 1
      slices:
        sub:
          match:
            type:
              coding: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
          schema:
            mustSupport: true
            index: 16
            elements:
              name: {short: Generic Name, mustSupport: true, index: 17}
              type:
                mustSupport: true
                index: 18
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
                    index: 19
                required: [coding]
              preferred: {mustSupport: true, index: 20}
            required: [type]
        gsrs:
          match:
            type:
              coding: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
          schema:
            mustSupport: true
            index: 21
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 22}
              type:
                mustSupport: true
                index: 23
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
                    index: 24
                required: [coding]
              preferred: {mustSupport: true, index: 25}
            required: [type]
        isbt:
          match:
            type:
              coding: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
          schema:
            mustSupport: true
            index: 26
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 27}
              type:
                mustSupport: true
                index: 28
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
                    index: 29
                required: [coding]
              preferred: {mustSupport: true, index: 30}
            required: [type]
  classification:
    short: Substance Type
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification'}
    mustSupport: true
    index: 2
  grade:
    short: Quality Standard
    index: 3
    elements:
      coding:
        binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology'}
        index: 4
  code:
    mustSupport: true
    index: 7
    elements:
      code:
        mustSupport: true
        index: 8
        elements:
          coding:
            index: 9
            slicing:
              rules: open
              discriminator:
              - {path: system, type: value}
              min: null
              slices:
                unii:
                  match: {system: 'http://fdasis.nlm.nih.gov'}
                  schema:
                    short: UNII
                    index: 10
                    elements:
                      system:
                        pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                        index: 11
                    required: [system]
                uniProt:
                  match: {system: 'https://www.uniprot.org'}
                  schema:
                    short: UniProt ID
                    index: 12
                    elements:
                      system:
                        pattern: {type: Uri, value: 'https://www.uniprot.org'}
                        index: 13
                    required: [system]
    required: [code]
  identifier: {short: optional user designated identifier, index: 1}
  manufacturer:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization']
    index: 5
  sourceMaterial:
    mustSupport: true
    index: 31
    elements:
      type:
        short: Source Type
        index: 32
        elements:
          coding:
            binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology'}
            index: 33
      genus:
        mustSupport: true
        index: 34
        elements:
          coding: {index: 35}
          text: {short: Source Organism, index: 36}
        required: [text]
      species:
        short: Source Organism
        mustSupport: true
        index: 37
        elements:
          coding: {index: 38}
          text: {index: 39}
        required: [text]
      part:
        short: Source Organism Part
        mustSupport: true
        index: 40
        elements:
          coding: {index: 41}
          text: {index: 42}
        required: [text]
      countryOfOrigin:
        short: Source Organism Country of Origin
        constraint:
          cmc-iso-genc-overlap:
            human: Only country codes that are also member of GENC can be used.
            source: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
            severity: error
            expression: |-
              coding.where(
                  (system = 'urn:iso:std:iso:3166') and (
                      (code = 'ALA') or
                      (code = 'PSE') or
                      (code = 'SJM') or
                      (code = 'UMI')
                  )
              ).exists().not()
        mustSupport: true
        index: 43
        elements:
          coding:
            mustSupport: true
            index: 44
            elements:
              code:
                constraint:
                  cmc-only-ISO-3166-1-alpha-3: {human: Country must be a 3 letter country code, source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient', severity: error, expression: $this.length() = 3}
                mustSupport: true
                index: 45
            required: [code]
        required: [coding]
    required: [type]
package_version: 1.0.0-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: 1.0.0-ballot
required: [grade, name, sourceMaterial, code, classification]