FDA CDER Draft Process Validation Guidance Rev.

FDA Center for Drugs (CDER), Center for Biologics (CBER) and Center for Vetinary Medicine released a a draft revision to its old 1987 Process Validation gudiance. This guidance is entitled: “Process Validation: General Principles and Practices”.

The revisions include significant flexibllity including use of process design information (even if not performed under cGMPs) to support process validation conclusions) and they define 2 basic stages for Process Validation: Stage 1 – Process Design and Stage 2 Process Qualifications. Stage 2 includes qualification of Utilities and Equipment and Performance Qualification.