European Union药物生产质量管理规范GＵIDE ＴO GＯＯD MＡＮＵFACTURINＧ ＰRAＣＴIＣE FＯR MＥDＩCINAL ＰRODUCTS目 录第一章 质量管理CHＡPTER １： QＵＡLITY MANAGEMENT原则．.．．..．..．....．....................．.........．...．.......．．. ..．............．.．．..．．．.．..．．.．．.....．．．..........．. ．........... .．...．...........．......5Ｐrinciple．.....．.．...．．..．.．.．..．.......．.．．........．...．...．.．..．......．..............．...．．．.......．...．．.....．..．.．..．..........．.．.．....．．....．．．...．.....５质量保证．.......．.．..............．．.．.....．...．．．..．．..．.....．．.......．.... ........．..... .．．..．...．．....．.．...．..．......．.．..．..．．..．．..．.．..．．...． 5Qｕａlｉty Ａssｕraｎce....．．．...．....．.....．...．.．........．...．..．.．...........．..．......．...．...．..．...．....．．........．.．.．..．..........．．....．．．..．...... 5药物生产质量管理规范(GＭＰ）．........．.．．．.......．.．....．.．..．............．............．.....．...........．......．......．....．７Good Ｍaｎufactuｒiｎｇ Pracｔｉｃe foｒ Mediciｎal Producｔs.....．...．．.．...．．．.........．.．...................．.........．........．........7质量控制(ＱC) ............．..．....．...．.....．．..．．....．.....．．．..．..．.．．..．.．.....．．......．．...．..．.．..．.......．....．..．．...．.......．...．.．.．．..．9Ｑuaｌｉty Ｃonｔrol.．.....．..．.．.．...．.．．． .．..．．.......．.....．..．．.．.．.．.......．...．.．......．....．...．.．................．．...．．..．.．..．．.....．.......．......．9产品质量回忆..．．...．..．..．.......．. ....．..．.．........．...． ..．.．..．..．........．.．.....．.．...．...．．............．．.．．..．.．...．..．.．.．..........．.10第二章人员ＣHＡPTＥR 2： PERＳONNEL.....．.．....．..．.．..．.．．.．.....．...．.．...．......．....．.．....．.......．．.．．.．．.．.．...... .．．.．.．.11原则..．．.．....．....．.．．.．.．．..．..．..．．..．.．．..．...............．.....．..．..................．......．.．.．.....．...．.....．..．．．．．...．....．.．．.１1Pｒｉncｉple......．．....．......．．..．.........．.....．．..．...．...．...．....．.．．............．......．...．........．.．.....．．..．..．...．.．.．..．.．.．...11通则．.．..．...．..........．.....．...．..．．....．....．.．..．..．.．．...．．.......．..．......．....．.．......．...．.......．．.....．......．...．....．．.. 1２Ｇeneraｌ．．......．...．.......．........．....．...．.．.．.．..．...........．．....．...．．...．.．．..........．．.....．.．.....．．.．．......．.．. ...．.....．...1２ 核心人员..．．.．............．...．...．....．...．．...．．.....．．.....．....．..．.....．.．........．.．......．.．..．.......．......．...．.. ．........．．..．....．..．.．．.．.1２Ｋｅy Personｎｅl..．.．.．...............．...．...．.．.．.....．．.．.....．..．．...．..........．..．..．......．..．........．.......．．........．..．.........．..．...........１2培训..．..．..．．．..............．....．．．．.....．．................．....．....．........．......．...．．．..．．....................．．．...．...．...............．．............ 12Trainiｎg．..．.....．.．.．.．．．....．．.....．..．．．....．.．......．．...．..．..．..．............．.．....．．.．.．.．..．．..........．.....．....．. .........．...15人员卫生.．．．.．.．...．.....．........．..............．．.....．...．.......．．....．．．.................．.．．....．....．.．.．．.．．.......．．．.．.....．..．.．............．1６Pｅrsonｎel Hygiｅne...........．..．．.....．......．.．．.．....．．...．.......．...．.．．..．.．．．...．．..........．.......．．...．.．.．......．.．......．......．..．......16 第三章厂房和设备ＣHAPTER 3： ＰREMIＳＥS AＮD EQUIＰMEＮT.........．......．....．．..．....．......．.．.．.．...．...．..．.．．...．.. ．．.．．．........18 原则.....．..．......．．...．．．..．...．．....．..．．.．．...．.．.．...．...．..．.．..．．...........．...．....．．.．..．.．.............．...．.．............．......18Pｒinｃiｐle．....．..．..．...．....．.．．.....．.．..．....．....．.．..．.．...．......．．．．.．...．....．..........．．..．.．.............．.........．．．．.．..．......18 厂房...．........．...．.．..．.．...．．．...．..．.．..．．.．．..．.．..．.．.．．......．．........．..........．．..．．.．....．．..．..．.．..．.....．.．.．..．．．....．......１８Prｅｍisｅｓ.......．.......．......．..．.．..．.....．......．．.．..........．.....．.．.．....．．..．．..．.......．.............．..．．...．....．...．.........．..18通则.......．．．.....．..．．....．.．.....．．．..．.....．．．..．....．...．...．.．...．．．.．..．....．．．．..．....．..．．..．.....．.．．.........．.．.....．.．........．．18Gｅneral...．.．.．..．．..．.．....．..．.............．.....．....．.．.....．.．．......．...．....．...．.........．．．.....．．......．......．...．.....．．..．．．..．.18生产区.．．.....．．...．.．.....．.．．............．...．..．.............．...........．...．.．...．．.．....．．．.．．.......．...．..．....．...．.............．19Ｐroduｃｔion Area..．．.....．....．.......．.．.....．..．..．.．．....．......．......．...............．........．.....．.．.．.．......．..．．.....．．....．.19贮存区..．..．..．..．.．.．.....．.．..........．..．...........．......．．.．．.............．.．．．..．....．......．.．....．..．..．.....．...................21Stｏｒage Area..．．.．．..．.....．....．.．...........．....．...........．..．........．.．..．.．.．.........．.．．...．.....．.．..........．．．．...．.....．.．.２１ 质量控制区.．...．....．..．......．........．..．.．．........．...．...．......．..．.．...．....．...．.．.....．..．.....．.．.．．．．....．.．...．......2２Quａlity Controｌ Area.．...．.．..．.....．.．...．．.........．...．..．．..．．.．.......．．.．.．..．......．...．......．.．......．....．.．．..．.....．.22附助区..．.．.．．..．...．......．...．....................．.．..．．．....．...．．..．.．．....．..．....。