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| Url | http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs |
| Version | 2.0.0 |
| Status | active |
| Date | 2025-05-21T20:17:38+00:00 |
| Name | CmcCompSectionTypesVS |
| Title | eCTD sections Terminology |
| Experimental | False |
| Realm | us |
| Authority | hl7 |
| Description | Value set of all codes in Code system PQCMC Comp Section Types. |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: ValueSet cmc-comp-section-types-vs
FHIRhttp://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use| Code | Display |
| ich_3.2.s | Drug Substance |
| ich_3.2.s.1 | General Information |
| ich_3.2.s.2 | Manufacture |
| ich_3.2.s.2.1 | Manufacturers |
| ich_3.2.s.2.2 | Description of Manufacturing Process and Process Controls |
| ich_3.2.s.2.3 | Control of Materials |
| ich_3.2.s.2.4 | Controls of Critical Steps and Intermediates |
| ich_3.2.s.2.5 | Process Validation and/or Evaluation |
| ich_3.2.s.2.6 | Manufacturing Process Development |
| ich_3.2.s.3 | Characterisation |
| ich_3.2.s.3.1 | Elucidation of Structure and other Characteristics |
| ich_3.2.s.3.2 | Impurities |
| ich_3.2.s.4 | Control of Drug Substance |
| ich_3.2.s.4.1 | Specification |
| ich_3.2.s.4.2 | Analytical Procedures |
| ich_3.2.s.4.3 | Validation of Analytical Procedures |
| ich_3.2.s.4.4 | Batch Analyses |
| ich_3.2.s.4.5 | Justification of Specification |
| ich_3.2.s.5 | Reference Standards or Materials |
| ich_3.2.s.6 | Container Closure System |
| ich_3.2.s.7 | Stability |
| ich_3.2.s.7.1 | Stability Summary and Conclusions |
| ich_3.2.s.7.2 | Postapproval Stability Protocol and Stability Commitment |
| ich_3.2.s.7.3 | Stability Data |
| ich_3.2.p | Drug Product |
| ich_3.2.p.1 | Description and Composition of the Drug Product |
| ich_3.2.p.2 | Pharmaceutical Development |
| ich_3.2.p.2.1 | Components of the Drug Product |
| ich_3.2.p.2.2 | Drug Product |
| ich_3.2.p.2.3 | Manufacturing Process Development |
| ich_3.2.p.2.4 | Container Closure System |
| ich_3.2.p.2.5 | Microbiological Attributes |
| ich_3.2.p.2.6 | Compatibility |
| ich_3.2.p.3 | Manufacture |
| ich_3.2.p.3.1 | Manufacturer(s) |
| ich_3.2.p.3.2 | Batch Formula |
| ich_3.2.p.3.3 | Description of Manufacturing Process and Process Controls |
| ich_3.2.p.3.4 | Controls of Critical Steps and Intermediates |
| ich_3.2.p.3.5 | Process Validation and/or Evaluation |
| ich_3.2.p.4 | Control of Excipients |
| ich_3.2.p.4.1 | Specification |
| ich_3.2.p.4.2 | Analytical Procedures |
| ich_3.2.p.4.3 | Validation of Analytical Procedures |
| ich_3.2.p.4.4 | Justification of Specifications |
| ich_3.2.p.4.5 | Excipients of Human or Animal Origin |
| ich_3.2.p.4.6 | Novel Excipients |
| ich_3.2.p.5 | Control of Drug Product |
| ich_3.2.p.5.1 | Specification(s) |
| ich_3.2.p.5.2 | Analytical Procedures |
| ich_3.2.p.5.3 | Validation of Analytical Procedures |
| ich_3.2.p.5.4 | Batch Analyses |
| ich_3.2.p.5.5 | Characterisation of Impurities |
| ich_3.2.p.5.6 | Justification of Specifications |
| ich_3.2.p.6 | Reference Standards or Materials |
| ich_3.2.p.7 | Container Closure System |
| ich_3.2.p.8 | Stability |
| ich_3.2.p.8.1 | Stability Summary and Conclusion |
| ich_3.2.p.8.2 | Postapproval Stability Protocol and Stability Commitment |
| ich_3.2.p.8.3 | Stability Data |
| ich_3.2.a | Appendices |
| ich_3.2.a.1 | Facilities And Equipment |
| ich_3.2.a.2 | Adventitious Agents Safety Evaluation |
| ich_3.2.a.3 | Excipients |
| ich_3.2.r | Regional Information |
| ich_3.3 | Literature References |
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XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.