The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this quarter’s issue of Pharmeuropa 37.2 for comment. This chapter aims to facilitate the implementation of rapid microbiological methods (RMM), an expanding area of microbiology that is both innovative and diverse in nature. The revision of this chapter is part of the significant efforts made by the Ph. Eur. Commission (EPC) to support and accelerate the implementation of alternative RMMs, which are especially beneficial for short shelf-life products. By fulfilling stakeholder expectations in this fast-moving field, the EPC reaffirms its unwavering commitment to staying at the forefront of scientific progress.

General chapter 5.1.6 has undergone significant revision to reflect current methodologies and update implementation guidance for these alternative methods. It now clarifies the responsibilities of suppliers and users and includes new information to help users optimise implementation strategies by capitalising on suitable tests already performed and evaluating different implementation activities simultaneously. The primary validation subsection has also been updated and clarified, and the guidance on product-specific validation has been extensively revised and provides several examples of the validation strategy.

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

For more information on how to comment, please consult our “How to comment” guide. Comments from states parties to the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.