Eudralex Volume 3 Guideline on process validation for finished products - information and data to be provided in regulatory submissions

Eudralex Volume 3 Guideline on process validation for finished products - information and data to be provided in regulatory submissions

EMA Process Validation Guidance

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.