| Package | hl7.fhir.us.pq-cmc-fda |
| Type | ValueSet |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/us/pq-cmc-fda/https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/ValueSet-cmc-comp-section-types-vs.html |
| Url | http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs |
| Version | 2.0.0-ballot |
| Status | active |
| Date | 2024-12-12T01:58:44+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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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet cmc-comp-section-types-vs</b></p><a name=\"cmc-comp-section-types-vs\"> </a><a name=\"hccmc-comp-section-types-vs\"> </a><a name=\"cmc-comp-section-types-vs-en-US\"> </a><ul><li>Include these codes as defined in <code>http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use</code><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ich_3.2.s</td><td>Drug Substance</td></tr><tr><td>ich_3.2.s.1</td><td>General Information</td></tr><tr><td>ich_3.2.s.2</td><td>Manufacture</td></tr><tr><td>ich_3.2.s.2.1</td><td>Manufacturers</td></tr><tr><td>ich_3.2.s.2.2</td><td>Description of Manufacturing Process and Process Controls</td></tr><tr><td>ich_3.2.s.2.3</td><td>Control of Materials</td></tr><tr><td>ich_3.2.s.2.4</td><td>Controls of Critical Steps and Intermediates</td></tr><tr><td>ich_3.2.s.2.5</td><td>Process Validation and/or Evaluation</td></tr><tr><td>ich_3.2.s.2.6</td><td>Manufacturing Process Development</td></tr><tr><td>ich_3.2.s.3</td><td>Characterisation</td></tr><tr><td>ich_3.2.s.3.1</td><td>Elucidation of Structure and other Characteristics</td></tr><tr><td>ich_3.2.s.3.2</td><td>Impurities</td></tr><tr><td>ich_3.2.s.4</td><td>Control of Drug Substance</td></tr><tr><td>ich_3.2.s.4.1</td><td>Specification</td></tr><tr><td>ich_3.2.s.4.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.s.4.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.s.4.4</td><td>Batch Analyses</td></tr><tr><td>ich_3.2.s.4.5</td><td>Justification of Specification</td></tr><tr><td>ich_3.2.s.5</td><td>Reference Standards or Materials</td></tr><tr><td>ich_3.2.s.6</td><td>Container Closure System</td></tr><tr><td>ich_3.2.s.7</td><td>Stability</td></tr><tr><td>ich_3.2.s.7.1</td><td>Stability Summary and Conclusions</td></tr><tr><td>ich_3.2.s.7.2</td><td>Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td>ich_3.2.s.7.3</td><td>Stability Data</td></tr><tr><td>ich_3.2.p</td><td>Drug Product</td></tr><tr><td>ich_3.2.p.1</td><td>Description and Composition of the Drug Product</td></tr><tr><td>ich_3.2.p.2</td><td>Pharmaceutical Development</td></tr><tr><td>ich_3.2.p.2.1</td><td>Components of the Drug Product</td></tr><tr><td>ich_3.2.p.2.2</td><td>Drug Product</td></tr><tr><td>ich_3.2.p.2.3</td><td>Manufacturing Process Development</td></tr><tr><td>ich_3.2.p.2.4</td><td>Container Closure System</td></tr><tr><td>ich_3.2.p.2.5</td><td>Microbiological Attributes</td></tr><tr><td>ich_3.2.p.2.6</td><td>Compatibility</td></tr><tr><td>ich_3.2.p.3</td><td>Manufacture</td></tr><tr><td>ich_3.2.p.3.1</td><td>Manufacturer(s)</td></tr><tr><td>ich_3.2.p.3.2</td><td>Batch Formula</td></tr><tr><td>ich_3.2.p.3.3</td><td>Description of Manufacturing Process and Process Controls</td></tr><tr><td>ich_3.2.p.3.4</td><td>Controls of Critical Steps and Intermediates</td></tr><tr><td>ich_3.2.p.3.5</td><td>Process Validation and/or Evaluation</td></tr><tr><td>ich_3.2.p.4</td><td>Control of Excipients</td></tr><tr><td>ich_3.2.p.4.1</td><td>Specification</td></tr><tr><td>ich_3.2.p.4.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.p.4.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.p.4.4</td><td>Justification of Specifications</td></tr><tr><td>ich_3.2.p.4.5</td><td>Excipients of Human or Animal Origin</td></tr><tr><td>ich_3.2.p.4.6</td><td>Novel Excipients</td></tr><tr><td>ich_3.2.p.5</td><td>Control of Drug Product</td></tr><tr><td>ich_3.2.p.5.1</td><td>Specification(s)</td></tr><tr><td>ich_3.2.p.5.2</td><td>Analytical Procedures</td></tr><tr><td>ich_3.2.p.5.3</td><td>Validation of Analytical Procedures</td></tr><tr><td>ich_3.2.p.5.4</td><td>Batch Analyses</td></tr><tr><td>ich_3.2.p.5.5</td><td>Characterisation of Impurities</td></tr><tr><td>ich_3.2.p.5.6</td><td>Justification of Specifications</td></tr><tr><td>ich_3.2.p.6</td><td>Reference Standards or Materials</td></tr><tr><td>ich_3.2.p.7</td><td>Container Closure System</td></tr><tr><td>ich_3.2.p.8</td><td>Stability</td></tr><tr><td>ich_3.2.p.8.1</td><td>Stability Summary and Conclusion</td></tr><tr><td>ich_3.2.p.8.2</td><td>Postapproval Stability Protocol and Stability Commitment</td></tr><tr><td>ich_3.2.p.8.3</td><td>Stability Data</td></tr><tr><td>ich_3.2.a</td><td>Appendices</td></tr><tr><td>ich_3.2.a.1</td><td>Facilities And Equipment</td></tr><tr><td>ich_3.2.a.2</td><td>Adventitious Agents Safety Evaluation</td></tr><tr><td>ich_3.2.a.3</td><td>Excipients</td></tr><tr><td>ich_3.2.r</td><td>Regional Information</td></tr><tr><td>ich_3.3</td><td>Literature References</td></tr></table></li></ul></div>"
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]
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]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.