Microbiology - EDQM asks for Comments on the new or revised Chapters

The European Pharmacopoeia (Ph. Eur.) has recently published a whole series of chapters with microbiological relevance and is asking for comments on the drafts.

Rapid methods

This concerns both rapid microbiological methods and the area of endotoxin/pyrogen testing.
For example, the EDQM is asking for comments on the general chapter 5.1.6 Alternative methods for microbiological quality control, which was published in the quarterly edition of Pharmeuropa 37.2.

The aim of this chapter is to facilitate the use of rapid microbiological methods (RMM), an increasingly important area of microbiology that is both innovative and versatile. The revision of this chapter is part of the comprehensive activities of the Ph. Eur. Commission (EPC) to support and accelerate the introduction of alternative RMMs, which are particularly beneficial for products with a short shelf life.

It is a fundamental revision that aims to reflect current methods and updates the guidance on the use of these alternative methods. It now clarifies the responsibilities of providers and users and includes new information to help users optimise their implementation strategies by using appropriate tests already conducted and evaluating different implementation activities simultaneously. The subsection on primary validation has also been updated and clarified, and the guidance on product-specific validation has been extensively revised and includes several examples of validation strategy.

The draft general chapter has now been published in Pharmeuropa 37.2, where it will be available for public consultation until the end of June 2025. All interested parties are invited to review the draft and provide their comments.

Further chapters

In addition, chapters 2.6.14. Bacterial endotoxins, 5.1.13. Pyrogenicity and  2.7.38. Bacteriophage potency determination are also included in the "Pharmeuropa 37.2 just released" list, which invites comments from experts and stakeholders.

If you would like to know more about the current activities of the Ph.Eur. in the field of microbiology before the end of the comment period, we recommend the European Microbiology Conference from 20-22 May in Vienna, where representatives of the EDQM will report on the new chapters and representatives of the USP, JP and ChP will also present the updates of these pharmacopoeias.