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PIC/S Provides Guidance to Inspectors on Assessing Quality Risk Management

Apr 7th, 2012

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The inter-agency Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” intended to assist GMP inspectors in assessing industry’s implementation of quality risk management (QRM) and to help promote a harmonized approach among PIC/S member states.

The Aide-Memoire notes that QRM aspects should be integral to the planning and content of all GMP inspections, including those involving both final products and active pharmaceutical ingredients (APIs).

PIC/S clarifies that the existence of this separate QRM document “does not suggest that specific inspections for QRM systems are performed.”  Instead, the goal is to focus during general inspections on how the company has integrated QRM into its operations.

The Aide-Memoire was adopted by the PIC/S in mid-March, and became effective on April 2.

What reviewers and inspectors will look for in their assessment of QRM has been drawing a good deal of discussion at public forums in the wake of ICH’s refinement of the underlying principles, as the agencies and industry work to incorporate them into regulatory and quality system processes.

The PIC/S guide is an effort to help address some of the questions that the expanding emphasis on QRM raises.  Given the current breadth of PIC/S membership, which now includes FDA, the new guide has significant implications for inspection practice in the evolving quality regulatory paradigm.

[The story continues for subscribers beginning on page 2, and includes insights from agency experts on the use of the Aide-Memoire and on how the risk management component of inspections is currently being conducted in Europe.  Nonsubscribers can purchase the full story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related stories:

FDA GMP Compliance Spotlight Will Remain Centered on Conventional Aseptic Processing

GDPs, APIs, and non-European GMPs on PIC/S Radar Screen as Membership Expands

PIC/S’ Voluntary, Non-Political Status Touted by Regulators Involved

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