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...........................................................................................