Draft guideline on process validation

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Download document Draft guideline on process validation
Reference number EMA/CHMP/CVMP/QWP/70278/2012-Rev1
Status draft: consultation closed
First published 13/04/2012
Last updated 13/04/2012


This guideline replaces the previous guideline on process validation. The guideline is brought into line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process verification described in the previous guideline has been added.