ICH Q9 "GMP Risk Management"

GMP News No. 472

GMP News
29 September 2004

ICH Q9 "GMP Risk Management"

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

The scope of this new guideline is determined by ICH to define how principles of risk management can be more effectively applied and consistently 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 Management actually means and how it works. Above all the guiding principle should be, that whatever you do during your process it should ultimately link back 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 important statement Razzaghi makes on initiating risk management is that one should define at this early step how assessment information and conclusions will be used by the decision makers. Furthermore, he points out that one should always ask "What are the impacts of current risk management decisions on future options for risk management?". A questions that is often neglected. At the end of his talk Razzaghi pays much attention to the integration of Quality Risk Management into operations, into daily routine work. He emphasizes that Risk Management is a tool that should be used during development and regulatory scrutiny. Risk Management is also a vital part of the Quality System from auditing to change management. It has to be applied in facility systems management (e.g. hygiene, qualification, computerized systems). It should be adopted to materials management, production, laboratory controls, packaging and labeling as well as regulatory authority activities. This list reflects ICH Q9's lifecycle approach.

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

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

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

The ICH Q9 Initiative on GMP Risk Management will be presented by Dr Stephan Rönninger, Hoffmann-La Roche. Dr Rönninger is Member of the ICH Expert Group Q9 and will give a lecture at the 7th European Conference on Active Pharmaceutical Ingredients to be held in Lisbon, Portugal, from 20-22 October 2004.

The application of Risk Management in Qualification and Validation will be discussed at ECA's European Conference "Sterile Manufacturing – Qualification and Validation", 18-19 October, 2004, Berlin, Germany.

Dr Ulrich Herber

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