The European Directorate for the Quality of Medicines & HealthCare (EDQM) is pleased to announce that it is organising a workshop to explore a certification system for the validation of rapid microbiological methods (RMMs), that will be of interest to suppliers and users of RMM equipment.

Microbiological analysis using conventional methods for the detection of micro-organisms mostly relies on culture methods which, though easy to use, reliable and well established, are time consuming. In recent years, several advances have been made with the development of new technologies and techniques. RMMs are an expanding area of microbiology and are both innovative and diverse in nature. These new technologies offer many advantages, including considerable time-savings and increased accuracy and precision when compared with conventional methods.

While the European Pharmacopoeia Commission has made significant efforts to facilitate the use of RMMs with the publication of general chapter 5.1.6. Alternative methods for control of microbiological quality, the use of RMM in the quality control of pharmaceutical products is still limited. Further efforts are therefore needed to support and accelerate the implementation of alternative RMMs.

This workshop will explore the feasibility of establishing a centralised certification system for the evaluation and validation of RMMs. Early discussions and exchanges have already taken place to investigate the different possible approaches to reviewing and validating RMMs and this event will allow further examination of the concept and provide stakeholders with an opportunity to give their input on their needs for such a system.

It is expected that the workshop, which will take place in Strasbourg on 15 and 16 October 2024, will bring together a wide range of experts in the pharmaceutical and microbiological fields, from Europe and beyond.

More information will be published shortly.