PIC/S releases revised guide on qualification and validation studies for pharma manufacturing

PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities.

The new guide is intended for both inspectors and industry stakeholders, providing clearer expectations on how to design, conduct, and document qualification and validation activities.

Adoption of the revised guidance aims to harmonize practices across member countries and support consistent compliance with good manufacturing standards.