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Guidance to Inspectors on Assessing Quality Risk Management 

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” for GMP inspectors and for pharmaceutical organisations. The guide aims to provide support information for the implementation of quality risk management (QRM).

The document states that QRM aspects should be integral to the planning and content of all GMP inspections and that QRM should be integrated in all operations. 

According to PIC/S: 

“The Aide-Memoire has been developed by the PIC/S Expert Circle on Quality Risk Management. The purpose of the document is to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Parts of the Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similar principals of QRM also apply.”