18 February 2008
EMEA:
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.
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