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Paul J. Newby - Articles and news items

Implementation, validation and registration of rapid microbiological methods

Issue 3 2008, Past issues / 19 June 2008 /

Over the last decade, interest in rapid microbiological methods (RMMs) in the pharmaceutical sector has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and considerable hesitancy associated with the introduction of these methods into the pharmaceutical sector. The aim of this article is to help clear up some of these issues in light of recent published literature.

Implementation, validation and registration

Issue 2 2005, Past issues / 20 May 2005 / Paul J Newby PhD, GlaxoSmithKline R&D

In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and considerable hesitancy associated with the introduction of these methods into the pharmaceutical sector.

 

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