description: Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product. package_name: hl7.fhir.us.pq-cmc-fda derivation: constraint name: ComponentSubstance 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-component-substance', severity: error, expression: select(preferred = true).count() < 2} mustSupport: true index: 19 elements: preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 20} 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: 21 elements: name: {short: Generic Name, mustSupport: true, index: 22} type: mustSupport: true index: 23 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: 24 required: [coding] preferred: {mustSupport: true, index: 25} 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: 26 elements: name: {short: GSRS Preferred Term, mustSupport: true, index: 27} type: mustSupport: true index: 28 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: 29 required: [coding] preferred: {mustSupport: true, index: 30} 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: 31 elements: name: {short: ISBT-128 DIN, mustSupport: true, index: 32} type: mustSupport: true index: 33 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: 34 required: [coding] preferred: {mustSupport: true, index: 35} 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 structure: mustSupport: true index: 7 elements: representation: index: 8 elements: representation: {mustSupport: true, index: 9} format: elements: coding: binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology'} index: 10 document: type: Reference short: Substance Structure Graphic mustSupport: true refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference'] index: 11 required: [representation] code: mustSupport: true index: 12 elements: code: mustSupport: true index: 13 elements: coding: index: 14 slicing: rules: open discriminator: - {path: system, type: value} min: null slices: unii: match: {system: 'http://fdasis.nlm.nih.gov'} schema: short: UNII index: 15 elements: system: pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'} index: 16 required: [system] uniProt: match: {system: 'https://www.uniprot.org'} schema: short: UniProt ID index: 17 elements: system: pattern: {type: Uri, value: 'https://www.uniprot.org'} index: 18 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: 36 elements: type: short: Source Type index: 37 elements: coding: binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology'} index: 38 genus: mustSupport: true index: 39 elements: coding: {index: 40} text: {short: Source Organism, index: 41} required: [text] species: short: Source Organism mustSupport: true index: 42 elements: coding: {index: 43} text: {index: 44} required: [text] part: short: Source Organism Part mustSupport: true index: 45 elements: coding: {index: 46} text: {index: 47} 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-component-substance 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: 48 elements: coding: mustSupport: true index: 49 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-component-substance', severity: error, expression: $this.length() = 3} mustSupport: true index: 50 required: [code] required: [coding] package_version: 1.0.0-ballot class: profile kind: resource url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition version: 1.0.0-ballot required: [grade, name, code, classification]