{
"description": "Value set of all codes in Code system PQCMC Comp Section Types.",
"compose": {
"include": [ {
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"concept": [ {
"code": "ich_3.2.s",
"display": "m3.2.s drug substance"
}, {
"code": "ich_3.2.s.1",
"display": "m3.2.s.1 general information"
}, {
"code": "ich_3.2.s.2",
"display": "m3.2.s.2 manufacture"
}, {
"code": "ich_3.2.s.2.1",
"display": "m3.2.s.2.1 manufacturer(s)"
}, {
"code": "ich_3.2.s.2.2",
"display": "m3.2.s.2.2 description of manufacturing process and process controls"
}, {
"code": "ich_3.2.s.2.3",
"display": "m3.2.s.2.3 control of materials"
}, {
"code": "ich_3.2.s.2.4",
"display": "m3.2.s.2.4 controls of critical steps and intermediates"
}, {
"code": "ich_3.2.s.2.5",
"display": "m3.2.s.2.5 process validation and/or evaluation"
}, {
"code": "ich_3.2.s.2.6",
"display": "m3.2.s.2.6 manufacturing process development"
}, {
"code": "ich_3.2.s.3",
"display": "m3.2.s.3 characterisation"
}, {
"code": "ich_3.2.s.3.1",
"display": "m3.2.s.3.1 elucidation of structure and other characteristics"
}, {
"code": "ich_3.2.s.3.2",
"display": "m3.2.s.3.2 impurities"
}, {
"code": "ich_3.2.s.4",
"display": "m3.2.s.4 control of drug substance"
}, {
"code": "ich_3.2.s.4.1",
"display": "m3.2.s.4.1 specification"
}, {
"code": "ich_3.2.s.4.2",
"display": "m3.2.s.4.2 analytical procedures"
}, {
"code": "ich_3.2.s.4.3",
"display": "m3.2.s.4.3 validation of analytical procedures"
}, {
"code": "ich_3.2.s.4.4",
"display": "m3.2.s.4.4 batch analyses"
}, {
"code": "ich_3.2.s.4.5",
"display": "m3.2.s.4.5 justification of specification"
}, {
"code": "ich_3.2.s.5",
"display": "m3.2.s.5 reference standards or materials"
}, {
"code": "ich_3.2.s.6",
"display": "m3.2.s.6 container closure system"
}, {
"code": "ich_3.2.s.7",
"display": "m3.2.s.7 stability"
}, {
"code": "ich_3.2.s.7.1",
"display": "m3.2.s.7.1 stability summary and conclusions"
}, {
"code": "ich_3.2.s.7.2",
"display": "m3.2.s.7.2 post-approval stability protocol and stability commitment"
}, {
"code": "ich_3.2.s.7.3",
"display": "m3.2.s.7.3 stability data"
}, {
"code": "ich_3.2.p",
"display": "m3.2.p drug product"
}, {
"code": "ich_3.2.p.1",
"display": "m3.2.p.1 description and composition of the drug product"
}, {
"code": "ich_3.2.p.2",
"display": "m3.2.p.2 pharmaceutical development"
}, {
"code": "ich_3.2.p.2.1",
"display": "m3.2.p.2.1 components of the drug product"
}, {
"code": "ich_3.2.p.2.2",
"display": "m3.2.p.2.2 drug product"
}, {
"code": "ich_3.2.p.2.3",
"display": "m3.2.p.2.3 manufacturing process development"
}, {
"code": "ich_3.2.p.2.4",
"display": "m3.2.p.2.4 container closure system"
}, {
"code": "ich_3.2.p.2.5",
"display": "m3.2.p.2.5 microbiological attributes"
}, {
"code": "ich_3.2.p.2.6",
"display": "m3.2.p.2.6 compatibility"
}, {
"code": "ich_3.2.p.3",
"display": "m3.2.p.3 manufacture"
}, {
"code": "ich_3.2.p.3.1",
"display": "m3.2.p.3.1 manufacturer(s)"
}, {
"code": "ich_3.2.p.3.2",
"display": "m3.2.p.3.2 batch formula"
}, {
"code": "ich_3.2.p.3.3",
"display": "m3.2.p.3.3 description of manufacturing process and process controls"
}, {
"code": "ich_3.2.p.3.4",
"display": "m3.2.p.3.4 controls of critical steps and intermediates"
}, {
"code": "ich_3.2.p.3.5",
"display": "m3.2.p.3.5 process validation and/or evaluation"
}, {
"code": "ich_3.2.p.4",
"display": "m3.2.p.4 control of excipients"
}, {
"code": "ich_3.2.p.4.1",
"display": "m3.2.p.4.1 specifications"
}, {
"code": "ich_3.2.p.4.2",
"display": "m3.2.p.4.2 analytical procedures"
}, {
"code": "ich_3.2.p.4.3",
"display": "m3.2.p.4.3 validation of analytical procedures"
}, {
"code": "ich_3.2.p.4.4",
"display": "m3.2.p.4.4 justification of specifications"
}, {
"code": "ich_3.2.p.4.5",
"display": "m3.2.p.4.5 excipients of human or animal origin"
}, {
"code": "ich_3.2.p.4.6",
"display": "m3.2.p.4.6 novel excipients"
}, {
"code": "ich_3.2.p.5",
"display": "m3.2.p.5 control of drug product"
}, {
"code": "ich_3.2.p.5.1",
"display": "m3.2.p.5.1 specification(s)"
}, {
"code": "ich_3.2.p.5.2",
"display": "m3.2.p.5.2 analytical procedures"
}, {
"code": "ich_3.2.p.5.3",
"display": "m3.2.p.5.3 validation of analytical procedures"
}, {
"code": "ich_3.2.p.5.4",
"display": "m3.2.p.5.4 batch analyses"
}, {
"code": "ich_3.2.p.5.5",
"display": "m3.2.p.5.5 characterisation of impurities"
}, {
"code": "ich_3.2.p.5.6",
"display": "m3.2.p.5.6 justification of specifications"
}, {
"code": "ich_3.2.p.6",
"display": "m3.2.p.6 reference standards or materials"
}, {
"code": "ich_3.2.p.7",
"display": "m3.2.p.7 container closure system"
}, {
"code": "ich_3.2.p.8",
"display": "m3.2.p.8 stability"
}, {
"code": "ich_3.2.p.8.1",
"display": "m3.2.p.8.1 stability summary and conclusion"
}, {
"code": "ich_3.2.p.8.2",
"display": "m3.2.p.8.2 post-approval stability protocol and stability commitment"
}, {
"code": "ich_3.2.p.8.3",
"display": "m3.2.p.8.3 stability data"
}, {
"code": "ich_3.2.a",
"display": "m3.2.a appendices"
}, {
"code": "ich_3.2.a.1",
"display": "m3.2.a.1 facilities and equipment"
}, {
"code": "ich_3.2.a.2",
"display": "m3.2.a.2 adventitious agents safety evaluation"
}, {
"code": "ich_3.2.a.3",
"display": "m3.2.a.3 excipients"
}, {
"code": "ich_3.2.r",
"display": "m3.2 r regional information"
}, {
"code": "ich_3.3",
"display": "m3.3 literature references"
} ]
} ]
},
"_filename": "ValueSet-cmc-comp-section-types-vs.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"date": "2025-07-08T07:43:10+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"name": "CmcCompSectionTypesVS",
"type": null,
"experimental": "false",
"resourceType": "ValueSet",
"title": "eCTD sections Terminology",
"package_version": "2.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 2,
"_valueInteger": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
} ]
}
} ],
"status": "active",
"id": "716f3446-d72c-4e5f-8d8d-72d01df05225",
"kind": null,
"url": "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.36.48.2",
"system": "urn:ietf:rfc:3986"
} ],
"version": "2.0.0",
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "brr@lists.HL7.org",
"system": "email"
} ]
} ]
}