PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems
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
- Annex
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.
Compiled by
Sven Pommeranz.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
18.09.2024Large Number of Deficiencies at Indian Manufacturer leads to Warning Letter
11.09.2024Root Cause Analysis again Subject of FDA Warning Letter
04.09.2024FDA Warning Letter to US Manufacturer of non-sterile Drugs
21.08.2024Warning Letter to US Company due to Lack of Product and Process Control
14.08.2024FDA Warning Letter criticizes Supplier Qualification