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.....................................................................................................................................................5质量保证.......

3、....................................................................................................................................5QualityAssurance..................................................................................................................................

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

5、.....................................................................................................9QualityControl..........................................................................................................................................9产品质量回顾..................

6、................................................................................................................10第二章人员CHAPTER2:PERSONNEL..............................................................................................11原则............................................

7、..........................................................................................11Principle..................................................................................................................................11通则............................................

8、...............................................