📆 Effective 1 October 2026:
This document updates and renames the previous document, PI 006-3 dated 25 September 2007 titled ‘Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation’ following the revision of Annex 15 in 2015.
It comprises individual recommendations on various topics of interest relating to qualification and validation in pharmaceutical manufacturing establishments.
Purpose of the Document
The topics in this document reflect some of the areas in pharmaceutical manufacture identified by PIC/S Inspectorates which require additional guidance from that given in the PIC/S GMP Guide Annex 15.
The purpose of this document is therefore to provide guidance and a training resource for GMP inspectors and the pharmaceutical industry that promotes medicinal quality assurance through a GMP compliant validation program.