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GMP News No. 543
6 April 2005
ICHQ 9 on Quality Risk Management published!
The International Conferenceon Harmonization published today the guideline ICH Q9 Quality RiskManagement. This paper will be found in the European and US-FDA Americanregulations as a draft guideline. In further steps the document will beimplemented into the pharmaceutical regulations. The document might becomea new annex of the EU GMP code of practice.
Since several years, the topic "risk management" is one ofthe main topics in the field of GMP. In the drug product industry this isregulated through a norm (DIN EN ISO 14971) since quite some time now.However, the guideline became first more concrete in the area of drugproducts in the context of the drafts to the annex 15 to the EU GMP codeof practice. When the annex 15 became valid in the year 2001 therequirement for risk assessment became more important in the validatingactivities.
With the introduction of the FDA initiative Pharmaceutical cGMP for the21st century also the term of the risk-based approach appeared in thefield. The FDA relates the risk management not only to validatingactivities but even further: all activities of enterprises in the sense ofquality risk management should be examined with respect to the security ofpatients.
FDA would like to use risk management also for the prioritisation ofits inspections.
The topic plays in the meanwhile such an important role that in summer2003 a working group of the International Conference on Harmonisation (ICHQ9) started working on this topic. Here both representatives from theindustry as well as officials from the EU, USA and Japan are involved.
What does the document state? The entire quality risk managementprocess is supposed to be applied to the product life cycle. The qualityrisk management process means the following:
Fig.1 Process Flow of Quality RiskManagement
What can a concrete implementation into
ICHQ 9 Quality Risk Management Conference
Twomembers of the ICH Q9 Expert Working Group as well as further high-rankingspeakers from the industry and officials present the content and itsconsequences on 21 June 2005. The conference "ICH Q8 - PharmaceuticalDevelopment" will also take place on 21 June 2005.
BothICH conferences are part of the European GMP Conference organised by theUniversity of Heidelberg on 20/21 June in Heidelberg.
TheBApÖD and the European Compliance Academy are co-sponsors of these topevents. You find the program under http://www.gmp-conference.org.
Thedocument can here be downloaded: