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, 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 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

## Downloads

Page standards status: Informative

- Full Specification (zip)

  Contains the entire Implementation Guide.

- JSON Definitions (zip)

  All profiles and value sets that are used in this Implementation Guide in JSON file format.

- XML Definitions (zip)

  All profiles and value sets that are used in this Implementation Guide in XML format.

- XML Examples (zip)

  All the examples that are used in this Implementation Guide.

- Validator (PACK File)

  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.

- NarrativeTransform (zip)

  Scripts to insert narratives in XML bundle files.