QRM Implementation: PIC/S Aide-Mémoire & Assessment Guide

Pharmaceutical Inspection#

Co-operation Scheme (PIC/S)#

Leading the international development, implementation, and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products,

PIC/S has revised the guidance document for Quality Risk Management (QRM) on 19 January 2021, (Geneva),

• PI 038-2 Aide-Memoire on Assessment of QRM Implementation

The revision process consisted in updating the cross-references to the PIC/S GMP Guide. No other changes were made. The revised Aide Memoires enter into force on 1 January 2021.

The purpose of PI 038-2 Aide-Memoire is to assist GMP inspectors in the assessment of QRM implementation in the industry during regulatory inspections. Parts of this Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similar principles of QRM also apply

This Aide-Memoire should also contribute to a harmonized approach for inspection of QRM in industry between the different PIC/S Members.

The PI 038-2 Aide-Memoire on Assessment of QRM Implementation document has well explained the views and expectations of the Regulatory Authority in the following parts,

1. Overall Systems
2. Expectations on how QRM should be implemented
3. Specific areas and activities where implementation of QRM might be expected
4. Review of residual risk
5. Review and improvement of QRM activities

To read the entire Aide-Memoire published by PIC/S Click here

This Short Note is published as a news update only; however, the detailed article on Quality Risk Management will be available shortly.

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