药品生产企业GMP文件分类与编码方法探讨

GMPGMP(050031)GMP,GMP:ISO9000,,GMP:R95412:A:1002-7777(2003)06-0374-03DiscussionontheClassifyingandCodingMethodforGMPDocumentsHaoYunjie(ShijiazhuangHuashuPharmaceuticalFactory,HebeiProvince,050031)ABSTRACTAnewclassifyingandcodingmethodforGMPdocumentsisprovided,inwhichtheISO9000documentsystemasbasicframe,thecurrentGoodManufacturingPracticeascontents,andtheadvantagesofthecurrentclassifyingmethodconsidered.Themethodhasthefeaturesofsystematization,regularizationandconvenienceforthedocuments.KEYWORDSGMPdocument;classification;codingGMPGMP,cGMP,SubpartJ;(1998):,GMPGMP,,,,,,21750,22HPLCA1;B1219Vc20007050720gml-1,100(101),40gml-13C,,,HPLC,,C1,,1HPLCC1,1992,12(1):184732003176©1995-2004TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.,,GMP:GMPGMP[1],,,,;,,,;GMPGMP,,,GMP,:ISO9000,,,,11GMP,,,FDA,,,ISO9000,,1,,,,,,,,,;,,,SMP,,SMP,,,GMP,SOP,,,2,,,5732003176©1995-2004TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.,,,,3,,,,,,;4,GMP,,,,,,,,,,,,,,,,22,SMP,SOP;,,01,SOP03;,,,,SOP0301;,,SOP030101;1,,00,RevXX,XX,00SOP030101A/Rev01SOP030101,,,,11GMP1,2000,16(4):3418,522,,88,;,,35%;;6732003176©1995-2004TsinghuaTongfangOpticalDiscCo.,Ltd.Allrightsreserved.