{
"description": "Value set of all codes in Code system PQCMC Comp Section Types.",
"compose": {
"include": [ {
"system": "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use",
"concept": [ {
"code": "ich_3.2.s",
"display": "Drug Substance"
}, {
"code": "ich_3.2.s.1",
"display": "General Information"
}, {
"code": "ich_3.2.s.2",
"display": "Manufacture"
}, {
"code": "ich_3.2.s.2.1",
"display": "Manufacturers"
}, {
"code": "ich_3.2.s.2.2",
"display": "Description of Manufacturing Process and Process Controls"
}, {
"code": "ich_3.2.s.2.3",
"display": "Control of Materials"
}, {
"code": "ich_3.2.s.2.4",
"display": "Controls of Critical Steps and Intermediates"
}, {
"code": "ich_3.2.s.2.5",
"display": "Process Validation and/or Evaluation"
}, {
"code": "ich_3.2.s.2.6",
"display": "Manufacturing Process Development"
}, {
"code": "ich_3.2.s.3",
"display": "Characterisation"
}, {
"code": "ich_3.2.s.3.1",
"display": "Elucidation of Structure and other Characteristics"
}, {
"code": "ich_3.2.s.3.2",
"display": "Impurities"
}, {
"code": "ich_3.2.s.4",
"display": "Control of Drug Substance"
}, {
"code": "ich_3.2.s.4.1",
"display": "Specification"
}, {
"code": "ich_3.2.s.4.2",
"display": "Analytical Procedures"
}, {
"code": "ich_3.2.s.4.3",
"display": "Validation of Analytical Procedures"
}, {
"code": "ich_3.2.s.4.4",
"display": "Batch Analyses"
}, {
"code": "ich_3.2.s.4.5",
"display": "Justification of Specification"
}, {
"code": "ich_3.2.s.5",
"display": "Reference Standards or Materials"
}, {
"code": "ich_3.2.s.6",
"display": "Container Closure System"
}, {
"code": "ich_3.2.s.7",
"display": "Stability"
}, {
"code": "ich_3.2.s.7.1",
"display": "Stability Summary and Conclusions"
}, {
"code": "ich_3.2.s.7.2",
"display": "Postapproval Stability Protocol and Stability Commitment"
}, {
"code": "ich_3.2.s.7.3",
"display": "Stability Data"
}, {
"code": "ich_3.2.p",
"display": "Drug Product"
}, {
"code": "ich_3.2.p.1",
"display": "Description and Composition of the Drug Product"
}, {
"code": "ich_3.2.p.2",
"display": "Pharmaceutical Development"
}, {
"code": "ich_3.2.p.2.1",
"display": "Components of the Drug Product"
}, {
"code": "ich_3.2.p.2.2",
"display": "Drug Product"
}, {
"code": "ich_3.2.p.2.3",
"display": "Manufacturing Process Development"
}, {
"code": "ich_3.2.p.2.4",
"display": "Container Closure System"
}, {
"code": "ich_3.2.p.2.5",
"display": "Microbiological Attributes"
}, {
"code": "ich_3.2.p.2.6",
"display": "Compatibility"
}, {
"code": "ich_3.2.p.3",
"display": "Manufacture"
}, {
"code": "ich_3.2.p.3.1",
"display": "Manufacturer(s)"
}, {
"code": "ich_3.2.p.3.2",
"display": "Batch Formula"
}, {
"code": "ich_3.2.p.3.3",
"display": "Description of Manufacturing Process and Process Controls"
}, {
"code": "ich_3.2.p.3.4",
"display": "Controls of Critical Steps and Intermediates"
}, {
"code": "ich_3.2.p.3.5",
"display": "Process Validation and/or Evaluation"
}, {
"code": "ich_3.2.p.4",
"display": "Control of Excipients"
}, {
"code": "ich_3.2.p.4.1",
"display": "Specification"
}, {
"code": "ich_3.2.p.4.2",
"display": "Analytical Procedures"
}, {
"code": "ich_3.2.p.4.3",
"display": "Validation of Analytical Procedures"
}, {
"code": "ich_3.2.p.4.4",
"display": "Justification of Specifications"
}, {
"code": "ich_3.2.p.4.5",
"display": "Excipients of Human or Animal Origin"
}, {
"code": "ich_3.2.p.4.6",
"display": "Novel Excipients"
}, {
"code": "ich_3.2.p.5",
"display": "Control of Drug Product"
}, {
"code": "ich_3.2.p.5.1",
"display": "Specification(s)"
}, {
"code": "ich_3.2.p.5.2",
"display": "Analytical Procedures"
}, {
"code": "ich_3.2.p.5.3",
"display": "Validation of Analytical Procedures"
}, {
"code": "ich_3.2.p.5.4",
"display": "Batch Analyses"
}, {
"code": "ich_3.2.p.5.5",
"display": "Characterisation of Impurities"
}, {
"code": "ich_3.2.p.5.6",
"display": "Justification of Specifications"
}, {
"code": "ich_3.2.p.6",
"display": "Reference Standards or Materials"
}, {
"code": "ich_3.2.p.7",
"display": "Container Closure System"
}, {
"code": "ich_3.2.p.8",
"display": "Stability"
}, {
"code": "ich_3.2.p.8.1",
"display": "Stability Summary and Conclusion"
}, {
"code": "ich_3.2.p.8.2",
"display": "Postapproval Stability Protocol and Stability Commitment"
}, {
"code": "ich_3.2.p.8.3",
"display": "Stability Data"
}, {
"code": "ich_3.2.a",
"display": "Appendices"
}, {
"code": "ich_3.2.a.1",
"display": "Facilities And Equipment"
}, {
"code": "ich_3.2.a.2",
"display": "Adventitious Agents Safety Evaluation"
}, {
"code": "ich_3.2.a.3",
"display": "Excipients"
}, {
"code": "ich_3.2.r",
"display": "Regional Information"
}, {
"code": "ich_3.3",
"display": "Literature References"
} ]
} ]
},
"_filename": "ValueSet-cmc-comp-section-types-vs.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"date": "2024-12-11T13:47:08+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": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"status": "active",
"id": "7aa8bc5b-2c54-48c1-9c27-65027b26fb7b",
"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": "1.0.0",
"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"
} ]
} ]
}