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
| Page standards status: Informative |
Contains the entire Implementation Guide.
All profiles and value sets that are used in this Implementation Guide in JSON file format.
All profiles and value sets that are used in this Implementation Guide in XML format.
All the examples that are used in this Implementation Guide.
A package that contains all the files necessary to validate a resource when used in conjunction with the FHIR Validator. Refer to Validating Resources on the FHIR website.
Scripts to insert narratives in XML bundle files.
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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QA Report
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