Extensive revisions of the EU GMP guide and GDP guidelines on the table

Last February the European Medicines Agency (EMA) published its Work Programme for 2011 where it outlined the main EMA priorities for 2011.

The EMA has recently released a more specific “Work plan for GMP/GDP Inspectors Working Group for 2011”, outlining the main activities for this particular group for 2011, which are as follows:

- Meetings scheduled for 2011
- Inspections under the centralised system
- Mutual Recognition Agreements (MRAs)
- Harmonisation Topics
- GMP and GDP Topics
- Collaboration with European Commission
- Liaison with other groups
- Other

Below is a summary of the main EMA plans for 2011. Please pay due attention to the information outlined below:

1.	Meetings Scheduled for 2011
	Four meetings have been scheduled during 2011, including a meeting with a Quality Working Party and the Group’s Interested Parties.
2.	Inspections under the Centralised System
	The GMP/GDP Inspectors Working group will be focussing essentially on the development and co-ordination of inspections relating to centrally authorised products, Plasma Master Files and Vaccine Antigen Master Files. The Working Group will also focus on the co-ordination of re-inspection of manufacturers in third countries where no Mutual Recognition Agreements (MRAs) are in place.
3.	Mutual Recognition Agreements (MRAs)
	Work will continue to improve the systems and usage supporting the MRA. Specifically, the Group will focus on further developing the Agreements where work is already in progress: MRA with Canada MRA with Japan ACCA with Israel
4.	Harmonisation Topics
	This Group will ensure that the agreed audit programme for 2011 is carried out. They will also increase the performance of GMP Audits. The Group will continue to identify GMP and GDP related topics for development as Community procedures. In this regard, the Group is expecting to include Community format for Wholesale Distribution Authorisation, GDP Certificates and GDP non-compliance statements depending on the final requirements of the anti-falsification legislation.
5.	GMP and GDP Topics
	Most of this work will be done in some changes and developments within the GMP Guide. So what are those main changes? Chapter 1 (Quality Managements) and Chapter 2 (Personnel) The Group will work on the finalisation of changes as part of the EU implementation of ICH Q10. Chapter 3 (Premises) and Chapter 5 (Equipment and Production) The GMP/GDP Inspectors Working Group will develop further the work done to date on sharing proposals and consultation with the US FDA before the initiation of a public consultation on dedicated and self-contained facilities. The Group will also finalise the amendments to Chapter 5 on the manufacture of API in accordance with GMP, analytic of raw materials, qualification of the supplier chain and traceability of starting materials. Chapter 6 (Quality Control) The Group will to undertake public consultation with the objective of identifying the minimal requirements for the transfer of analytics methods. Chapter 7 (Contract Manufacture and Analysis / Outsources Activities) Finalisation of the review to broaden its scope as per the EU's implementation of ICH Q10. Chapter 8 (Complaints and Product Recall) To initiate a revision following discussion at a meeting held in October 2009 to implement specific Quality Risk Management concepts. Annex 2 (Biological substances and Medical Products) Finalise the revision of Annex 2 following the public consultation carried out in 2010. Annex 15 (Validation) The Annex will be reviewed with the intention of maintaining consistency with the new CHMP guideline on process validation. Annex 16 (Certification by a QP and Batch Release) This Group will take into account recent changes to the GMP Guide and other developments such as PAT and Real Time Release Testing. Annex 17 (Parametric Release) Revision of Annex 17 with respect to the revision of the CHMP guideline on Parametric Release/Real Time Release Testing. Good Distribution Practice (GDP) The Group will finalise a revision of EU GDP Guidelines. Once this is finished, the Group will submit its findings to the European Commission to release a public consultation, which will have to take into account any changes that might be necessary to accommodate the newly implemented anti-falsification legislation.
6.	Collaboration with European Commission
	In the areas of EudraGMP database, implementation of anti-falsification legislation or part III of the EU GMP Guide.
7.	Liaison with other groups
	In order to continue a fluent dialogue with stakeholders and external groups in areas of common interest.

For further information you can download the document published by the European Medicines Agency.

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004875.pdf