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/cmc-organization'] index: 4 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: 27 elements: type: binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type'} index: 28 preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 29} 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: 30 elements: name: {short: Generic Name, mustSupport: true, index: 31} 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: 32 preferred: {mustSupport: true, index: 33} 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: 34 elements: name: {short: GSRS Preferred Term, mustSupport: true, index: 35} 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: 36 preferred: {mustSupport: true, index: 37} 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: 38 elements: name: {short: ISBT-128 DIN, mustSupport: true, index: 39} 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: 40 preferred: {mustSupport: true, index: 41} required: [type] 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 structure: constraint: cmc-structure-representation-required: human: Either a file or string structure representation is required source: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance severity: error expression: |- representation.type.coding.where( system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C45253' | 'C103240')) ).exists() index: 5 elements: representation: short: Impurity Structure Graphic | Impurity Structure Data File mustSupport: true index: 6 elements: type: binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types'} mustSupport: true index: 7 required: [type] slicing: rules: closed ordered: false discriminator: - {path: type, type: value} min: null slices: graphic: match: type: coding: - {code: C54273, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} schema: short: A graphical, displayable depiction of the structure (e.g. an SVG, PNG) index: 8 elements: type: short: Graphic pattern: type: CodeableConcept value: coding: - {code: C54273, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} index: 9 document: type: Reference short: Impurity Structure Graphic refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference'] index: 10 required: [document] structureFile: match: type: coding: - {code: C103240, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} schema: short: machine-readable representation -- attached file array: true index: 11 elements: type: short: Structure File pattern: type: CodeableConcept value: coding: - {code: C103240, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} index: 12 document: type: Reference short: Impurity Chemical Structure Data (files, e.g. .SDF, .CIF) mustSupport: true refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference'] index: 13 required: [document] structureString: match: type: coding: - {code: C45253, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} schema: short: machine-readable representation -- plain text array: true index: 14 elements: type: short: Structure Textual pattern: type: CodeableConcept value: coding: - {code: C45253, system: 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'} index: 15 representation: {short: 'Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)', mustSupport: true, index: 16} format: short: Drug Substance Impurity Method Type binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology'} mustSupport: true index: 17 required: [representation, format] code: mustSupport: true index: 18 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: 19 elements: code: mustSupport: true index: 20 elements: coding: mustSupport: true index: 21 elements: system: pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'} mustSupport: true index: 22 required: [system] required: [coding] required: [code] uniProt: match: code: coding: {system: 'https://www.uniprot.org'} schema: short: UniProt ID index: 23 elements: code: mustSupport: true index: 24 elements: coding: mustSupport: true index: 25 elements: system: pattern: {type: Uri, value: 'https://www.uniprot.org'} mustSupport: true index: 26 required: [system] required: [coding] required: [code] identifier: {short: optional user designated identifier, index: 0} manufacturer: type: Reference mustSupport: true refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization'] index: 3 sourceMaterial: mustSupport: true index: 42 elements: type: short: Source Type binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology'} mustSupport: true index: 43 genus: {type: CodeableConcept, short: Source Organism Genus, mustSupport: true, index: 44} species: {type: CodeableConcept, short: Source Organism Species, mustSupport: true, index: 45} part: {type: CodeableConcept, short: Source Organism Part, mustSupport: true, index: 46} 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: 47 package_version: 2.0.0-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: 2.0.0-ballot required: [grade, name, code, classification]