欧盟gmp中英文对照

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1、TherulesgoverningmedicinalproductsintheEuropeanUnion药品生产质量管理规范EuropeanUnion药品生产质量管理规范GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS65TherulesgoverningmedicinalproductsintheEuropeanUnion药品生产质量管理规范目录第一章质量管理CHAPTER1:QUALITYMANAGEMENT原则......................

2、...............................................................................................................................5Principle...........................................................................................................................

3、..........................5质量保证...........................................................................................................................................5QualityAssurance.........................................................................

4、............................................................5药品生产质量管理规范(GMP).................................................................................................7GoodManufacturingPracticeforMedicinalProducts.........................................

5、.....................................7质量控制(QC)...................................................................................................................................9QualityControl....................................................................

6、......................................................................9产品质量回顾..................................................................................................................................10第二章人员CHAPTER2:PERSONNEL............................

7、..................................................................11原则......................................................................................................................................11Principle.............................................

8、.....................................................................................11通则...........................................................................................