Outline of a project to rationalise international GMP inspection activities

As part of its collaboration with international medicines regulators on good manufacturing practice (GMP) inspections, the European Medicines Agency (EMEA), in July 2008, coordinated a group of participating regulators (EU Member States, US Food and Drug Administration and Australian Therapeutic Goods Administration) and published a proposal for the coordination of inspection plans between them. The proposal formed part of international efforts to rationalise the use of global GMP inspection resources by simplifying the administrative tasks relating to inspections and by avoiding the unnecessary duplication of inspection work.