European inspectors set out plans for 2009

Judging by the workplan of the Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) Inspectors Working Group of the European Medicines Agency (EMEA), 2009 is going to be a busy one in terms of GMP/GDP activity. (For information about this group visit http://www.emea.europa.eu/Inspections/docs/gmpgdpworkplan.pdf).

On Mutual Recognition Agreements (MRAs), the Group will seek to harmonise the operational aspects of all MRAs. On specific MRAs, it will seek to work towards extension of the operational aspects under the current scope of the MRA with Japan.

It will also assist new member states to prepare for evaluation by Health Canada under the MRA with that country.

There will also be a large amount of activity on revision and updating on various aspects of the European Union Guide on GMP.

Topics that will be pursued include continued work on updating the current guidance on dedicated self-contained manufacturing facilities and further consultation on a revision to Annex 2 to the Guide on biological medicinal products.

There will also be a certain amount of review of the Guide to take account of the implementation of ICH Guidelines Q8, 9, and 10 on pharmaceutical development, quality risk management and pharmaceutical quality systems respectively.

On the issue of anti-counterfeiting measures, the Group will develop an implementation strategy for the new legislative proposals with respect to GMP/GDP inspection-related aspects and it is foreseen that this will involve revision of the GDP Guideline and certain aspects of the GMP Guide.

The plan for the year is an ambitious one and will require the involvement of all stakeholders to ensure its fulfilment.