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webinar

How to master raw material ID testing in 2021

11 November 2020 | By Thermo Fisher Scientific

In this webinar taking place on 9 December, we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021. Reserve your free virtual seat today!

article

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.

article

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…