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.
PIC/S Recommendations on Quality System Requirements for Pharmaceutical Inspectorates (PI 002-3)Sept 2007
This document specifies the quality system requirements for National pharmaceutical inspection services concerned with good manufacturing practice and good wholesale distribution practice of medicinal products.
PIC/S Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-5) July 2017
This procedure covers transmission of information by means of a Rapid Alert between the different parties relating to the recall of medicinal products which have quality defects, including counterfeit or tampered products, when urgent action is required to protect public health and animal health.