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Analytical techniques

 

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Primary validation of the growth direct bioburden system and media

30 October 2020 | By , , , ,

This article presents statistics required to validate rapid microbial methods (RMMs) according to the requirements in the most recent version of European Pharmacopoeia (EP) 5.1.6. The validation methods for bioburden test application performed are also described.

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European Pharmaceutical Review Issue 5 2020

16 October 2020 | By

In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…