EMA plans extensive Revision of the EU GMP Guide

At the beginning of this year, the European Medicines Agency (EMA) published the Work Plan for GMP/GDP (Good Manufacturing Practice/Good Distribution Practice) Inspectors Working Group. This document provides a good overview of the changes upcoming in the GMP/GDP environment - and it might come to a lot of changes. The document is divided into 8 chapters:

1. Meetings scheduled for 2011
2. Inspections under the Centralised System
3. Mutual Recognition Agreements (MRAs)
4. Harmonisation topics
5. Collaboration with European Commission
6. Zusammenarbeit mit der Europäischen Kommission
7. Liaison with other groups
8. Other

In the following, you will find more details about item 5 "GMP and GDP topics". What are the EMA's plans?

EU GMP Guide

• Chapter 1 (Quality Management) and 2 (Personnel): Finalisation of the changes as part of the implementation of ICH Q10
• Chapter 3 (Premises and Equipment) and 5 (Production): Sharing proposals and consultation with the US FDA before the initiation of a public consultation on dedicated and self-contained facilities. Finalisation of 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): Public consultation on the revision of this chapter for minimal requirements for the transfer of analytical methods. 
• Chapter 7 (Contract Manufacture and Analysis/Outsourced Activities): Finalisation of the revision regarding the implementation of ICH Q10 aspects.
• Chapter 8 (Complaints and Product Recall): Initiation of a revision to implement specific Quality Risk Management concepts.
• Annex 2 (Biological substances and Medicinal Products): Finalisation of the revision following the public consultation carried out in 2010.
• Annex 15 (Validation): Revision of Annex 15 including the implementation of ICH Q8, Q9 and Q10 aspects in order to maintain consistency with the CHMP guideline on process validation. The planed revision of the chapters 3 and 5 ("dedicated facilities") will also be taken into account.
• Annex 16 (Certification by a QP and Batch Release): Initiation of a revision in regard to the recent modifications to the GMP Guide: developments such as PAT, Real Time Release, globalisation, legislation on counterfeiting prevention, control reports for batches moving between the Member States, sampling and testing of batches produced in third countries, dealing with minor deviations from marketing authorisations.
• Annex 17 (Parametric Release): Revision of Annex 17 with regard to the revision of the CHMP guideline on Parametric Release/Real Time Release Testing.
• Good Distribution Practice (GDP): Finalisation of a draft of the Community GDP guideline and forwarding to the European Commission for public consultation. Starting work on GMP guidance about storage during transport.

Conclusion: Again, the GMP/GDP Inspectors Working Group has set itself an ambitious goal. Some of the items mentioned above had already been listed in last year's plan (see our GMP News from 8 March 2010) and will be implemented in 2011. Even if not all goals are actually achieved within 2011, the pharmaceutical industry will have to reckon with marked changes. We will keep you posted about these changes.

For further details please see the complete document.

Compiled by
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)