The PIC/S has recently published an Aide-Memoire for GMP inspectors on inspections of quality risk management (QRM) systems that became effectove on 2 April 2012. The document is composed of 10 pages organised in 6 chapters:
- 1 Document history
- 2 Introduction
- 3 Purpose
- 4 Scope
- 5 Aide-Memoire
- 6 Revision history
The introduction focuses on the importance of a functioning and monitored QA system. A QRM system should be embedded into this QA system.
Chapter 3 defines the purpose of this Aide-Memoire, namely to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Moreover, it is pointed out that parts of this Aide-Memoire may also be useful (with suitable modification) during other GxP inspections.
In the scope part, the Aide-Memoire is presented as the current state of the art but is not intended to be a barrier to technical innovation or the pursuit of excellence. This Aide-Memoire mainly relies on the corresponding mandatory articles of Chapter 1 and Annex 15 of the PIC/S GMP Guide as the ICH Q9 Document is not binding for an inspection. The chapter Aide-Memoire expressly defines that dedicated time is required to be allocated to review the QRM system during an inspection.
Chapter 6 should include a revision history. This part is empty as the document has been published for the first time.
The actual Aide-Memoire divides the inspection issues as an annex into 5 sub-chapters:
- 1 Overall Systems (including 12 significant indicators and related issues, i.e. involvement of the upper management).
- 2 Expectations on how QRM should be implemented (including 14 significant indicators and related issues)
- 3 Specific areas and activities where implementation of QRM might be expected (including 17 significant indicators and related issues)
- 4 Review of residual risk (including 8 significant indicators and related issues)
- 5 Review and improvement of QRM activities (including 7 significant indicators and related issues)
Conclusion: the PIC/S Aide-Memoire on inspection of QRM systems is very interesting and may be helpful also for the pharmaceutical industry to get fresh perspectives. The document may be used as a checklist for every one's QRM system.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)