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Rapid Microbiological Methods Regulatory Perspectives

EDQM Symposium on Microbiology10-11 October 201711/10 2017 EDQM, Council of Europe. 2017 EDQM, Council of Europe. All rights reserved. 1 European Pharmacopoeia Chapter Methods for control of Microbiological qualityS bastien Jouette, Ph. programme officer, European Pharmacopoeia DepartmentEuropean Directorate for the Quality of Medicines and 2017 EDQM, Council of Europe. All rights Alternative Methods for control of Microbiological quality AIM: to facilitate the implementation anduse of alternative Microbiological Methods (AMM) where this can lead to cost-effective Microbiological control and improved assurance for the quality of pharmaceutical products.

Some methods have been removed (e.g.micro-calorimetry, phage-based method) ... • Parallel testing is justified by a risk assessment and requires parallel testing of samples ... Example of equivalence testing for a rapid sterility test based on ATP bioluminescence:

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