欧盟GMP规范_2009

玲4冷EUROPEAN COMMISSION☆ENTERPRISE AND INDUSTRY DIRECTORATE-GENERALConsumer goodsPharmaceuticalsBrussels,14 February 2008EudraLexThe Rules Governing Medicinal Products in the European UnionVolume 4EU Guidelines toGood Manufacturing PracticeMedicinal Products for Human and Veterinary UseAnnex 1Manufacture of Sterile Medicinal ProductsDocument HistoryPrevious version dated 30 May 2003,in operation sinceSeptember 2003Revision to align classification table of clean rooms,to includeNovember 2005 toguidance on media simultations,bioburden monitoring and cappingDecember 2007of freeze-dried vialsDate for coming into operation and superseding01 March 2009!Note:Provisions on capping of freeze-dried vials should be implemented by 01 March 2010.Commission Europeenne,B-1049 Bruxelles Europese Commissie,B-1049 Brussel-Belgium.Telephone:(32-2)299 11 11