GMP News No. 543
6 April 2005
ICH Q 9 on Quality Risk Management published!
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
ICH Q 9 Quality Risk Management Conference
Two members of the ICH Q9 Expert Working Group as well as further high-ranking speakers from the industry and officials present the content and its consequences on 21 June 2005. The conference "ICH Q8 - Pharmaceutical Development" will also take place on 21 June 2005.
Both ICH conferences are part of the European GMP Conference organised by the University of Heidelberg on 20/21 June in Heidelberg.
The BApÖD and the European Compliance Academy are co-sponsors of these top events. You find the program under http://www.gmp-conference.org.
document can here be downloaded: