May 2022
Real CMC Tips and Insights

published 1 Jun 2022

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in May 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.


EudraGMDP ( is a very useful public database of pharmaceutical manufacturers, importers, and wholesale dealers, which can be used to verify GMP/GDP status but also (through the MIA/GMP Operations Search and the API Search) to identify sites approved to perform activities of interest. Historical data on UK sites remains in the database even now that the Brexit transition period has ended, but for more up-to-date information use the UK database with similar functionality: MHRA-GMDP (

ASMF Version Discrepancies

An ASMF may be submitted by an ASMF holder to support multiple MA or variation applications made by different applicants for different products. Each update to an ASMF, whether required during assessment or initiated by the ASMF holder, results in an updated ASMF version number. Discrepancies in version numbers are among the commonest validation issues, therefore it is crucial to confirm with the ASMF holder - before submitting - that the applicant’s part is the most recent available version and matches the restricted part submitted by the ASMF holder.

The Applicant’s Drug Substance Module

When an ASMF is used to submit information on a drug substance to competent authorities, the applicant must still present a drug substance module as follows: the applicant’s specifications and analytical procedures for the material in 3.2.S.4.1 and 3.2.S.4.2, analytical validation in 3.2.S.4.3 (if the applicant’s analytical procedures are not identical to those validated by the ASMF holder), batch analyses in 3.2.S.4.4, justification of specifications in 3.2.S.4.5 and information about reference standards in 3.2.S.5.


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