International GMP Guides?

A recent increase in the number of non-EU states carrying out GMP inspections in Europe has been evident over the past year or so. Together with the recent proposal by the Pharmaceutical Inspection Cooperation Scheme to set up a 'virtual' International Medicines Inspectorate and also the FDA's much publicised review of its inspection philosophy, a debate has developed on the desirability and feasibility of developing a fully international basis for GMP inspections. There is a plethora of GMP guides around the world, and although a number of Mutual Recognition Agreements (MRAs) on GMP inspection systems have, to some degree, minimised the need for inspection, there still seems to be a growing inspection burden on manufacturers supplying global markets.

Could an international GMP Guide be developed?

Superficially, the idea has obvious attractions, and the International Conference on Harmonisation (ICH) has been mooted as a possible route, encouraged by the highly successful development of the ICH Guideline Q7A on Active Pharmaceutical Ingredients (APIs). However, the development of such a guide for finished products will be a far more challenging exercise. Q7A started with a minimal number of guidelines and international regulatory requirements on this topic, and was derived and developed by an extremely focused team. The larger number and variety of philosophies in relation to finished product GMP could be a far more complex equation to solve.

The concept has much merit and certainly the debate will be involved and interesting. No doubt we will all express our views as the plot unfolds.