Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/cmc-comp-section-types-vs | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | Computable Name: CmcCompSectionTypesVS | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.2 | ||||
Value set of all codes in Code system PQCMC Comp Section Types.
References
This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)
Generated Narrative: ValueSet cmc-comp-section-types-vs
http://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 |
No Expansion for this valueset (Unknown Code System)
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change