Aide-Memoire from the PIC/S regarding the Inspection of Quality Risk Management

Recommendation

4/5 October 2022
Heidelberg, Germany

Process Validation in the light of the revised Annex 15 and FDA Requirements

The PIC/S has developed a stand-alone Aide-Memoire (PI 038-2) on Quality Risk Management (QRM) for GMP inspectors. The aim of the document is to provide guidance to GMP inspectors on the inspection of QRM systems in the pursuit of harmonisation. The focus of the document lies on Chapter 1 Part I and Annex 15 of the EU (PIC/S) GMP Guide.

The Aide-Memoire includes nine pages, divided into six chapters:
1) Document history
2) Introduction
3) Purpose
4) Scope
5) Aide-Memoire
6) Revision history

The questions on content start in Chapter 5 (Aide-Memoire). Questions are then posed, always with reference to Chapter 1 GMP Guide Part I and the ICH Q10, on the following topics:

• Overall system
• Expectations on how a QRM should be implemented
• Specific areas and activities where implementation of QRM might be expected
• Review of residual risk
• Review and improvement of QRM activities

The Aide-Memoire is helpful because it publicly provides the questions that a GMP inspector should ask regarding the implementation and application of QRM. However, answers to these questions are not included. The Aide-Memoire is available on the PIC/S website.