Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, 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 | |||
| Standards status: Trial-use | Maturity Level: 2 | 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)
http://terminology.hl7.org/CodeSystem/ICHContextOfUse| Code | Display |
| ich_3.2.s | m3.2.s drug substance |
| ich_3.2.s.1 | m3.2.s.1 general information |
| ich_3.2.s.2 | m3.2.s.2 manufacture |
| ich_3.2.s.2.1 | m3.2.s.2.1 manufacturer(s) |
| ich_3.2.s.2.2 | m3.2.s.2.2 description of manufacturing process and process controls |
| ich_3.2.s.2.3 | m3.2.s.2.3 control of materials |
| ich_3.2.s.2.4 | m3.2.s.2.4 controls of critical steps and intermediates |
| ich_3.2.s.2.5 | m3.2.s.2.5 process validation and/or evaluation |
| ich_3.2.s.2.6 | m3.2.s.2.6 manufacturing process development |
| ich_3.2.s.3 | m3.2.s.3 characterisation |
| ich_3.2.s.3.1 | m3.2.s.3.1 elucidation of structure and other characteristics |
| ich_3.2.s.3.2 | m3.2.s.3.2 impurities |
| ich_3.2.s.4 | m3.2.s.4 control of drug substance |
| ich_3.2.s.4.1 | m3.2.s.4.1 specification |
| ich_3.2.s.4.2 | m3.2.s.4.2 analytical procedures |
| ich_3.2.s.4.3 | m3.2.s.4.3 validation of analytical procedures |
| ich_3.2.s.4.4 | m3.2.s.4.4 batch analyses |
| ich_3.2.s.4.5 | m3.2.s.4.5 justification of specification |
| ich_3.2.s.5 | m3.2.s.5 reference standards or materials |
| ich_3.2.s.6 | m3.2.s.6 container closure system |
| ich_3.2.s.7 | m3.2.s.7 stability |
| ich_3.2.s.7.1 | m3.2.s.7.1 stability summary and conclusions |
| ich_3.2.s.7.2 | m3.2.s.7.2 post-approval stability protocol and stability commitment |
| ich_3.2.s.7.3 | m3.2.s.7.3 stability data |
| ich_3.2.p | m3.2.p drug product |
| ich_3.2.p.1 | m3.2.p.1 description and composition of the drug product |
| ich_3.2.p.2 | m3.2.p.2 pharmaceutical development |
| ich_3.2.p.2.1 | m3.2.p.2.1 components of the drug product |
| ich_3.2.p.2.2 | m3.2.p.2.2 drug product |
| ich_3.2.p.2.3 | m3.2.p.2.3 manufacturing process development |
| ich_3.2.p.2.4 | m3.2.p.2.4 container closure system |
| ich_3.2.p.2.5 | m3.2.p.2.5 microbiological attributes |
| ich_3.2.p.2.6 | m3.2.p.2.6 compatibility |
| ich_3.2.p.3 | m3.2.p.3 manufacture |
| ich_3.2.p.3.1 | m3.2.p.3.1 manufacturer(s) |
| ich_3.2.p.3.2 | m3.2.p.3.2 batch formula |
| ich_3.2.p.3.3 | m3.2.p.3.3 description of manufacturing process and process controls |
| ich_3.2.p.3.4 | m3.2.p.3.4 controls of critical steps and intermediates |
| ich_3.2.p.3.5 | m3.2.p.3.5 process validation and/or evaluation |
| ich_3.2.p.4 | m3.2.p.4 control of excipients |
| ich_3.2.p.4.1 | m3.2.p.4.1 specifications |
| ich_3.2.p.4.2 | m3.2.p.4.2 analytical procedures |
| ich_3.2.p.4.3 | m3.2.p.4.3 validation of analytical procedures |
| ich_3.2.p.4.4 | m3.2.p.4.4 justification of specifications |
| ich_3.2.p.4.5 | m3.2.p.4.5 excipients of human or animal origin |
| ich_3.2.p.4.6 | m3.2.p.4.6 novel excipients |
| ich_3.2.p.5 | m3.2.p.5 control of drug product |
| ich_3.2.p.5.1 | m3.2.p.5.1 specification(s) |
| ich_3.2.p.5.2 | m3.2.p.5.2 analytical procedures |
| ich_3.2.p.5.3 | m3.2.p.5.3 validation of analytical procedures |
| ich_3.2.p.5.4 | m3.2.p.5.4 batch analyses |
| ich_3.2.p.5.5 | m3.2.p.5.5 characterisation of impurities |
| ich_3.2.p.5.6 | m3.2.p.5.6 justification of specifications |
| ich_3.2.p.6 | m3.2.p.6 reference standards or materials |
| ich_3.2.p.7 | m3.2.p.7 container closure system |
| ich_3.2.p.8 | m3.2.p.8 stability |
| ich_3.2.p.8.1 | m3.2.p.8.1 stability summary and conclusion |
| ich_3.2.p.8.2 | m3.2.p.8.2 post-approval stability protocol and stability commitment |
| ich_3.2.p.8.3 | m3.2.p.8.3 stability data |
| ich_3.2.a | m3.2.a appendices |
| ich_3.2.a.1 | m3.2.a.1 facilities and equipment |
| ich_3.2.a.2 | m3.2.a.2 adventitious agents safety evaluation |
| ich_3.2.a.3 | m3.2.a.3 excipients |
| ich_3.2.r | m3.2 r regional information |
| ich_3.3 | m3.3 literature references |
This value set contains 65 concepts
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 based on FHIR 5.0.0. Generated 2025-07-08
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