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 1.0.0-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

Change Notes

PQ/CMC FHIR Implementation Guide is underdevelopement. Minor releases will be posted for feedback. These release notes will be retained until the next major release. See the Directory of published versions link does not work until there is a balloted publication on HL7.

Changes and Updates for Version 1.0.0-ballot

The current development IG - Ballot review

• All changes from prior developemtn have been cleard