Publication of revised Ph. Eur. chapter on alternative microbiological methods

Alternative microbiological methods are increasingly used for pharmaceutical applications. To facilitate their implementation, the European Pharmacopoeia Commission (EPC) adopted the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, the revised general chapter has an implementation date of 1 April 2027.

While the overall implementation framework remains unchanged, in the process of revision, outdated quality control methods have been deleted and modern approaches to both the determination of the number of microorganisms and identification have been included. The new text also clarifies the principles for the implementation and validation of alternative methods and more clearly defines the respective responsibilities of suppliers and users.

Alternative methods may be used for microbiological quality control of the finished product and the manufacturing process. Unlike classical pharmacopoeia methods, alternative methods, provided they are properly validated for routine use, generally improve the quality of the analysis and significantly reduce the time required for its implementation, which allows, if necessary, timely and prompt implementation of corrective actions.

Source: www.coe.int