Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality

The European Pharmacopoeia Working Party Modern Microbiological Methods (MMM WP) is responsible for texts on Rapid Microbiological Methods (RMM) in Chapter 5.1.6 "Alternative Methods for Control of Microbiological Quality". Now they are revising this chapter referring to the recent technological developments.

To evaluate the experience of the users of chapter 5.1.6. since its implementation in 2006 and to learn about the potential need for improvements, the EDQM would like collect information of the users of this chapter and requested the" National Pharmacopoeia Authorities" (NPA) to provide the secretariat with information about the use of RMM and experience with implementation in their area of authority. For that reason they published a questionnaire and an attached document for comments to chapter 5.1.6.

The ECA RMM Working Group wants to support this request, because it is one of the group's visions to accomplish a better communication and understanding between authorities and industry before regulatory guidelines and documents are finalised.

Therefore, all members of the ECA Working Group can take advantage of the possibility to provide information on their experience and their comments to the request of the EDQM via the ECA RMM Working Group. We therefore set up a questionnaire. Deadline to complete this questionnaire is 6 August 2010. The results will be forwarded to the MMM WP and published on the ECA RMM Working Group's website.

Author:
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)