ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Sections 12 and 13: validation and change control – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 12.6: Periodically evaluate validated systems and processes to confirm they remain in a validated state

What does 12.6 require?

Systems and processes should be evaluated periodically to confirm they still operate validly. Where no significant change has been made and a quality review shows consistent production to specification, revalidation is normally not needed.

Maintained by Gerard Blokdyk

Other controls in Sections 12 and 13: validation and change control – ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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