Problems with the Integration of ICH Q9 into the European Regulatory System

Problemswith the Integration of ICH Q9 into the European Regulatory System

The European Medicines Agency (EMEA) is currently looking for the bestway to include the document into the European regulatory system. Ingeneral, there are two common possibilities for the Agency to do this: bypublishing it as a Note for Guidance, or as an Annex to the EU-GMP Guide.

Dueto the various possibilities to implement ICH Q9 Quality Risk Management, theintegration might make further explanatory documents necessary. Duringthe public consultation phase, it became clear e.g. that on the one handmanufacturers are not obliged to implement Quality Risk Management, on theother hand they can get significant advantages out of the implementation.Apart from that, the principles of risk management cannot only be appliedto production, but also to development and to the preparation of dossiersfor marketing authorisations. Furthermore, the guideline also concernsauthorities examining the quality part of dossiers as wellas GMP inspections and the handling of possible quality deficiencies.
  

How can Quality Risk Management be implemented inpractice? Examples for correct implementation are dealt with at the
ICH Q9 TrainingCourse 
on 31 May to 1 June in Prague.

 
Author:
Wolfgang Heimes
on behalf of ECA

Source: EMEA web page: http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf