The EMA has published the “Guideline on process validation for finished products – information and data to be provided in regulatory submissions”. This Guideline will come into effect on 15. July 2014.
This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged.
Download Guideline: EMA process validation final Feb 2014
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