Update on a pilot project to collaborate on international GMP inspection activities

As a follow-up to EMEA's proposal published in July 2008 outlining plans to coordinate inspection activities between a group of participating regulators, a revised paper providing an update on the status of activities was prepared by the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). The paper was published in January 2009.

The publication of the paper, which also includes key performance indicators and rules of engagement, marks the official beginning of an 18-month pilot programme for sharing inspections-related information between the participating regulators. These activities form part of international efforts to rationalise the use of global good manufacturing practice (GMP) inspection resources by sharing information and avoiding the unnecessary duplication of inspection work.

• Primary Source

European Medicines Agency: Statement: EMA/INS/GMP/232127/2010: Compliance and inspection (12.4.10): Enhancing quality assurance of API manufacture, April 2010 http://www.ema.europa.eu/pdfs/general/direct/internationalcoop/23212710en.pdf

Website: United States Food and Drug Administration http://www.fda.gov/

Website: Australian Governemnt: Department of Health and Ageing: Therapeutic goods administration http://www.tga.gov.au/

European Medicines Agency, (et al.): Pilot project to rationalise international GMP inspection activities - Rules of engagement and procedures for participating authorities (active pharmaceutical ingredients/active substances), January 2009 http://www.emea.europa.eu/Inspections/docs/41432308en.pdf

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