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 thepharmaceutical arena asICH Q9 "Quality Risk Management". Linked to FDA's new"Risk-Based Approach", this document shows the way to the future of thepharmaceutical industry. Risk management is meant to accompany apharmaceutical enterprise from development until after sales.

ICH Q9 is divided into three parts: a relatively general part focussing onthe "Quality Risk Management Process" itself, and two annexes. Annex Idescribes"Risk Management Methods and Tools", whereas Annex II listspotential areas of implementation for "Quality Risk Management". With only19 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 ofPowerPoint slides. These slides are directed both at regulators and at theindustry. They cover the background and the history of ICH Q9 as well asdetails on the tools listed in Annex I and the implementation areasmentioned in Annex II. After an introduction, the slide compilation startswith an "Executive Summary". The last part includes "Frequently AskedQuestions (Q&A)".

The description of the tools is complemented by extracts frompractical examples. For instance, the implementation of FMEA is shownwithin the framework of a drying process. For a fault tree analysis, apackaging problem is illustrated, an extract from a tabletting process isanalysed by means of the HACCP method, and for the HAZOP method there isalso a slide with a practical example. The topic of  "risk rankingand filtering" is demonstrated with the example of production problems.

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

In the introduction, the authors mention expressly that the examplesgiven are just one possible way of interpretation. The users of ICH Q9(and of these slides) have to choose their risk management methods andtools according to their own needs. Still the slides are worthwhilereading 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 requirementsas well as the content and the consequences of ICH's Q10 and the FDAGuidance for Industry on Quality Systems are in the centre of the EuropeanCompliance Academy's training course

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


Sven Pommeranz
On behalf of ECA


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