Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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

Resource Profile: QualitySpecification - Examples

Active as of 2024-04-04

Examples for the pqcmc-quality-specification Profile.

Cochineal specification Example
Water Specification Example
Citric acid specification Example
A quality specification is for a drug product
Carrageenan specification Example
A quality specification is for a drug substance