year, the European Pharmacopoeia Working Party Modern Microbiological
Methods (MMM WP), responsible for texts on Rapid Microbiological Methods
(RMM) in Chapter 5.1.6 published a questionnaire and document for
comments to chapter 5.1.6. With this questionnaire and the opportunity
to provide comments the Working Party wanted to evaluate the
experience of users of chapter 5.1.6. since it was implemented in
2006 and to learn about the potential need to revise this chapter. The
ECA Rapid Microbiological Methods (RMM) Working Group supported this
request with an online survey.
20% of the participants submitted applications concerning the
implementation of alternative methods for an approval or requested
scientific advice. Two thirds of the participants found the chapter
5.1.6. helpful for their implementation of alternative methods and ~ 75%
considered the given example in the chapter. Nearly 90% would be in
favour of having more examples.
detailed results representing close to 80 members of the ECA RMM Group
providing input will be presented at the “Rapid
Microbiological Methods Conference” in Budapest, Hungary, from 8 to
9 December 2010.