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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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