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
Page standards status: Trial-use | Maturity Level: 2 |
Examples for the cmc-ectd-document-32p32 Profile.
3.2.P.3.2 Bundle for liquid |
3.2.P.3.2 Bundle for two-layer tablet |