European Medicines Agency / US Food and Drug Administration joint GMP inspection pilot programme. General principles

The purpose of this document is 'to provide advice to applicants and describe the policies and procedures to be used by the European Medicines Agency (EMA) and the US Food and Drug Administration (US FDA) on the coordination and performance of joint EMA/US FDA GMP inspections.'

• Primary Source

EMA: News, 11.8.10: EMA and US FDA seek potential candidate companies for joint GMP inspection programme http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/08/news_detail_001102.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp&jsenabled=true

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

EMA/FDA: EMA / FDA joint GMP inspection pilot programme: Terms of reference and procedures for participating authorities (manufacturers of medicinal products) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/11/WC500098837.pdf

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