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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.
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