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Pharmaceutical Quality/Chemistry, Manufacturing and Controls Implementation Guide

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pq-cmc-fda

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

The Food and Drug Administration (FDA) PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls. This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. It profiles FHIR® documents to be submitted as XML files in Module 3 of the eCTD to the FDA. It was created under their sponsorship.

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FHIR® is the registered trademark of HL7.

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