PIC/S: How Inspectors should evaluate a PQS

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published a draft Recommendation with the aim to provide guidance on evaluating and demonstrating the effectiveness of a Pharmaceutical Quality System (PQS) in relation to risk-based change management.

The PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. This is detailed in Annex 15 of the respective Guide:

• 11.1. "The control of change is an important part of knowledge management and should be handled within the pharmaceutical quality system."
• 11.4. "Quality risk management should be used to evaluate planned changes… and to plan for any necessary process validation, verification or requalification efforts."
• 11.7. "…an evaluation of the effectiveness of change should be carried out…"

The Recommendation now seeks to provide practical guidance for GMP inspectors on how to assess these requirements. The document will help inspectors better understand what risk-based change management means. On the other hand, pharmaceutical companies might find guidance how they could demonstrate effectiveness of their risk-based change management system within the PQS, starting with the planning of the change until its final evaluation after implementation.