What is an ASMF?

14.02.2022

Question of the Week

An Active Substance Master File (ASMF) is a documentation created and maintained by the active substance manufacturer according to the specifications of Chapter 3.2.S of the format template for the EU authorisation dossier.

[GMP Compliance Adviser, Chapter 20.C.3]

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24.11.2025

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How is a QRM process initiated?

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