Microbiological quality – EDQM is asking for comments on the revised chapters 5.1.6.
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. “Alternative methods for control of microbiological quality”, which was published in the quarterly edition of Pharmeuropa 37.2 for comment and public consultation until the end of June 2025.
The aim of this chapter is to facilitate the implementation of rapid microbiological methods (RMM), an innovative and versatile approach in the field of microbiology.
The revision of this chapter is part of the overall efforts of the Ph. Eur. Commission (EPC) to support and accelerate the introduction of alternative RMMs, especially beneficial for products with a short shelf life.
The new revision clarifies the responsibilities of suppliers and users and includes new information to help users optimise their implementation strategies, taking advantage of the suitable tests already performed and evaluating different development activities simultaneously. The subsection on primary validation has also been updated and clarified, while the guidance on product-specific validation has undergone extensive revision with the addition of several examples.
The 54 drafts published in Pharmeuropa 37.2 are listed in the Newsroom “Pharmeuropa 37.2 just released”, which invites experts, users and interested parties to leave their comments
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