rapid endotoxin testing - Articles and news items

Review of regulatory changes impacting on pharamceutical microbiology

Review of regulatory changes impacting on pharamceutical microbiology

Issue 6 2014 / 23 December 2014 / Dr Tim Sandle, Bio Products Laboratory

This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology…

Article 5: The implementation of rapid microbiological methods

Issue 5 2010, Microbiology / RMMs / 1 November 2010 / Michael J. Miller, President, Microbiology Consultants, LLC

This is the fifth in a series of articles on rapid microbiological methods that will appear in European Pharmaceutical Review during 2010. In my previous four articles, I have provided an overview of the benefits of rapid microbiological methods (RMMs) as compared with conventional methods, validation strategies and regulatory perspectives on the implementation of RMMs, especially from the US FDA and the European Medicines Agency. Some regulatory authorities rely on the published literature as a means of staying current with regard to new technologies that are being introduced, in addition to which companies are implementing these technologies in their manufacturing facilities.


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