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18 February 2008

Revision of GMP Guidelines to implement concept of Quality Risk Management

As an implementation measure related to the ICH Q9 guideline on quality risk management, the European Commission has reviewed the existing GMP provisions. With the revision of GMP Part I, Chapter 1 on Quality Management quality risk management becomes an integral part of a manufacturer’s quality system. This concept will also be considered in a future revision of GMP Part II. The ICH Q9 guideline as such has been implemented with the new Annex 20. It should be noted that the new Annex is not intended, however, to create any new regulatory expectations; but rather provides an inventory of internationally acknowledged risk management methods and tools together with a list of potential applications at the discretion of manufacturers. For background on the implementation of these revisions please see the revised Introduction.