Pharmaceutical Microbiology Group

Survey to EP Chapter 5.1.6.

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This 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.

Approx. 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.

The 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.

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