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The International Conference
on Harmonization published today the guideline ICH Q9 Quality Risk
Management. This paper will be found in the European and US-FDA American
regulations as a draft guideline. In further steps the document will be
implemented into the pharmaceutical regulations. The document might become
a new annex of the EU GMP code of practice.
Since several years, the topic "risk management" is one of
the main topics in the field of GMP. In the drug product industry this is
regulated through a norm (DIN EN ISO 14971) since quite some time now.
However, the guideline became first more concrete in the area of drug
products in the context of the drafts to the annex 15 to the EU GMP code
of practice. When the annex 15 became valid in the year 2001 the
requirement for risk assessment became more important in the validating
activities.
With the introduction of the FDA initiative Pharmaceutical cGMP for the
21st century also the term of the risk-based approach appeared in the
field. The FDA relates the risk management not only to validating
activities but even further: all activities of enterprises in the sense of
quality risk management should be examined with respect to the security of
patients.
FDA would like to use risk management also for the prioritisation of
its inspections.
The topic plays in the meanwhile such an important role that in summer
2003 a working group of the International Conference on Harmonisation (ICH
Q9) started working on this topic. Here both representatives from the
industry as well as officials from the EU, USA and Japan are involved.
What does the document state? The entire quality risk management
process is supposed to be applied to the product life cycle. The quality
risk management process means the following:
Fig.1 Process Flow of Quality Risk
Management
What can a concrete implementation into
practice look like?
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