Transcription of European Pharmacopoeia Chapter 5.1.6 Alternative methods ...
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European Pharmacopoeia Chapter 5.1.6 Alternative methods ...
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. CONTENT: basic principles for detection, enumeration, isolation and identification of the methods which have successfully been used in QC of pharmaceuticals; guidance on validation of Alternative methods against 2017 EDQM, Council of Europe. All rights Symposium on Microbiology10-11 October 201711/10 2017 EDQM, Council of Europe.
the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used.
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