ICH Q9 - Training Material Published

GMP News No. 829

GMP News
31 October 2006

ICH Q9 - Training Material Published

Hardly any other document has recently caused such a sensation in the pharmaceutical arena as ICH Q9 "Quality Risk Management". Linked to FDA's new "Risk-Based Approach", this document shows the way to the future of the pharmaceutical industry. Risk management is meant to accompany a pharmaceutical enterprise from development until after sales.

ICH Q9 is divided into three parts: a relatively general part focussing on the "Quality Risk Management Process" itself, and two annexes. Annex I describes "Risk Management Methods and Tools", whereas Annex II lists potential areas of implementation for "Quality Risk Management". With only 19 pages, the document is quite short, since it is neither intended as a "recipe" nor as an SOP, but as a guideline.

In order to support the implementation of ICH Q9 in daily practice, some members of the ICH Q9 Expert Working Group have created a set of PowerPoint slides. These slides are directed both at regulators and at the industry. They cover the background and the history of ICH Q9 as well as details on the tools listed in Annex I and the implementation areas mentioned in Annex II. After an introduction, the slide compilation starts with an "Executive Summary". The last part includes "Frequently Asked Questions (Q&A)".

The description of the tools is complemented by extracts from practical examples. For instance, the implementation of FMEA is shown within the framework of a drying process. For a fault tree analysis, a packaging problem is illustrated, an extract from a tabletting process is analysed by means of the HACCP method, and for the HAZOP method there is also a slide with a practical example. The topic of  "risk ranking and filtering" is demonstrated with the example of production problems.

Also for Annex II to ICH Q9 there are slides with extracts of practical examples available. Two of them are "Risk Management Strategy for Excipients" and "Deviation/Investigation Report". The slides also include a detailed example showing how to plan an audit, a matrix for risk management in development, and a model risk assessment process in the field of facilities.

In the introduction, the authors mention expressly that the examples given are just one possible way of interpretation. The users of ICH Q9 (and of these slides) have to choose their risk management methods and tools according to their own needs. Still the slides are worthwhile reading for all those who want to deal with the forward-looking topic "Quality Risk Management" either for the first time or more intensively. They are also presentable enough to be used in training personnel.

The practical implementation of the ICH Q9 requirements as well as the content and the consequences of ICH's Q10 and the FDA Guidance for Industry on Quality Systems are in the centre of the European Compliance Academy's training course

"ICH Q9 Training Course" and "ICH Q10 and FDA Quality System Training Course"
in Berlin, Germany, from 20-22 June 2007.

The PowerPoint slides of the ICH Q9 training material can be found at: 

Sven Pommeranz
On behalf of ECA

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