Otober 2022
Real CMC Tips and Insights

published 11 Nov 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 October 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.


Acceptance Criteria for Microbiological Quality

Ph. Eur. and USP acceptance criteria for microbiological quality are interpreted as follows: - 101 CFU: maximum acceptable count is 20 not 10 - 102 CFU: maximum acceptable count is 200 not 100 and so on. This seems counterintuitive, but the leeway is meant to allow for the poor accuracy and precision of microbiological enumeration.


When a European Pharmacopoeia Chemical Reference Substance is available, European competent authorites will generally expect it to be used as the primary standard for the in-house qualification of secondary (working) standards. Other sources of primary standards are considered less authoritative in the region.

Structuring Module 3

A well-structured dossier is so much easier to evaluate. If you wish to facilitate review, list tests in the same order throughout the dossier: in the specifications table, when describing analytical procedures, when justifying specifcations, on COAs, and in the batch analyses and stability tables.



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