GMP News No. 671
14 February 2006
Problems with the Integration of ICH Q9 into the European Regulatory System
After the Steering Committee of the International Conference on Harmonisation (ICH) passed the document ICH Q9 "Quality Risk Management" on 9 November 2005 at step 4, now it is up to the EU to adopt it formally.
The European Medicines Agency (EMEA) is currently looking for the best way to include the document into the European regulatory system. In general, there are two common possibilities for the Agency to do this: by publishing it as a Note for Guidance, or as an Annex to the EU-GMP Guide.
to the various possibilities to implement ICH Q9 Quality Risk Management, the
integration might make further explanatory documents necessary. During
the public consultation phase, it became clear e.g. that on the one hand
manufacturers are not obliged to implement Quality Risk Management, on the
other hand they can get significant advantages out of the implementation.
Apart from that, the principles of risk management cannot only be applied
to production, but also to development and to the preparation of dossiers
for marketing authorisations. Furthermore, the guideline also concerns
authorities examining the quality part of dossiers as well
as GMP inspections and the handling of possible quality deficiencies.
To learn more about a risk-based approach with regards to
computer systems and electronic records, visit our course
The Risk-based Approach to Computer Validation
from 08 - 09 May in Berlin
How can Quality Risk Management be implemented in
practice? Examples for correct implementation are dealt with at the
Source: EMEA web page: http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf