ICH Q9 "GMP Risk Management"

GMP News No. 472

29 September 2004

ICH Q9 "GMP RiskManagement"

During the last meeting of FDA's Advisory Committee for PharmaceuticalScience (ACPS) Manufacturing Subcommittee on July 20-21, 2004 FrederickRazzaghi, Director of Technical Affairs, Consumer Healthcare ProductsAssociation, gave a noteworthy presentation on the new ICH guideline Q9"Risk Management".

The scope of this new guideline is determined by ICH to define howprinciples of risk management can be more effectively applied andconsistently integrated into decisions, both by regulators and industry,regarding the quality of pharmaceuticals across the product lifecycle,including GMP compliance.

After a short overview about recent ICH activities concerning Q9,Frederick Razzaghi explained in detail what Quality Risk Managementactually means and how it works. Above all the guiding principle shouldbe, that whatever you do during your process it should ultimately linkback to the potential risk to the patient.

Risk management itself can be divided into the following stages:Initiate Process, Assess, Control, Communicate and Review. An importantstatement Razzaghi makes on initiating risk management is that one shoulddefine at this early step how assessment information and conclusions willbe used by the decision makers. Furthermore, he points out that one shouldalways ask "What are the impacts of current risk management decisionson future options for risk management?". A questions that is oftenneglected. At the end of his talk Razzaghi pays much attention to theintegration of Quality Risk Management into operations, into daily routinework. He emphasizes that Risk Management is a tool that should be usedduring development and regulatory scrutiny. Risk Management is also avital part of the Quality System from auditing to change management. Ithas to be applied in facility systems management (e.g. hygiene,qualification, computerized systems). It should be adopted to materialsmanagement, production, laboratory controls, packaging and labeling aswell as regulatory authority activities. This list reflects ICH Q9'slifecycle approach.

Frederick Razzaghi's presentation is of great benefit to those who wantto stay informed about recent regulatory developments on Risk Managementas well as to those who want to understand how Risk Management willinfluence their daily work in the future.

An extra advantage of this presentation is the comprehensive list ofdefinitions to ensure that all have a common understanding of the termsused in Risk Management.

The slides of Frederick Razzaghi's presentation can be downloaded here.

Dr Ulrich Herber

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