EMA publishes ICH Q9 and ICH Q 10 as Part 3 of the EU GMP Guide

The EMA announced the adoption of ICH Q9 and ICH Q10 as Part 3 of the EU GMP Guide. ICH Q9 was already published as Annex 20 but ICH Q 10 was not published as an Annex yet.

The following explanation is taken from the EMA webpage:

Pharmaceutical Quality System (ICH Q10)

The ICH Q10 document on Pharmaceutical Quality System was adopted at Step 4 at the ICH Steering Committee meeting in June 2008. By virtue of Article 6 of Directive 2003/94/EC and Directive 91/412/EEC manufacturing authorisation holders are already obliged to establish and implement an effective pharmaceutical quality assurance system in order to comply with Good Manufacturing Practice (GMP) and guidance is provided in Chapter 1 of the GMP Guide. ICH Q10 provides an example of a pharmaceutical quality system designed for the entire product lifecycle and therefore goes beyond current GMP requirements, which with the exception of the manufacture of investigational medicinal products for human use, do not apply to the development part of the lifecycle. At the time of the EU implementation of ICH Q10 it was also recognised that Chapters 1, 2 and 7 of the GMP Guide should be updated to align with the terminology and concepts utilised in ICH Q10. The content of ICH Q10 that is additional to the scope of GMP is optional. Its use should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. Here you will find the document

 Quality Risk Management (ICH Q9)

The ICH Q9 document on Quality Risk Management was adopted at step 4 at the ICH Steering Committee meeting on 9 November 2005. 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. As part of the EU implementation of ICH Q9, an amendment to Chapter 1 of the GMP Guide (Quality Management) was published in February 2008 which came into force in July 2008. This amendment incorporated the principles of Quality Risk Management into the Chapter. The text of this document, formerly Annex 20, remains optional and provides examples of the processes and applications of Quality Risk Management. Here you will find the document

Source: EMA Webpage

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