PIC/S Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
This document comprises individual Recommendations on four topics relating to Equipment Qualification and Process Validation in pharmaceutical manufacture, as follows:
Validation Master Plan
Installation and Operational Qualification
Non-Sterile Process Validation
The four Recommendations comprising this document define general principles pertaining to each of the topics.