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EMA Process Validation Guidance Draft Open for Comment

The European Medicines Agency (EMA) has released a new draft Guideline on Process Validation following a similiar guidance issued by the US FDA last year.  There are a lot of similiarites including continous process verification and QbD principles.  The most notable difference on quick glance is the prescriptive nature of Annex I that outlines submission requirements. 

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/04/WC500125399.pdf

 

Chris Amstutz

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