Quality Risk Management
The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorisation dossier, GMP inspections and the handling of suspected quality defects.
Abstract
Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorisation dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorisation dossier, GMP inspections and the handling of suspected quality defects. Nevertheless for coherence the text was included within the GMP Guide as Annex 20 in March 2008. Since the creation of Part III of the GMP Guide it has been recognised that Part III is a more appropriate location for its publication.