中国GMP2010中英文对照ISPE翻译版

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1、《《《药品生产质量管理规范《药品生产质量管理规范药品生产质量管理规范（药品生产质量管理规范（（（2010年修订年修订）》年修订）》《《《GoodManufacturingPractice(2010revision)》》》ReviewedbyISPEMaYiling,ZhangJianye,YangYalanInitialTranslationfromNNEPharmaplan目录TableofContents第一章第一章第一章总总总总则则则则...............................

2、...................................................................................5Chapter1GeneralProvisions.........................................................................................5第二章质质质量管理质量管理..........................................

3、.................................................................6Chapter2Qualitymanagement....................................................................................6.第一节原则........................................................................

4、........................................6.Section1Principle........................................................................................................6.第二节质量保证..................................................................................

5、.......................6.Section2QualityAssurance.......................................................................................6.第三节质量控制.........................................................................................................8.Se

6、ction3QualityControl.............................................................................................8第三章机构与人员.........................................................................................................10Chapter3Organizationandpe

7、rsonnel..........................................................................10.第一节原则...........................................................................................................10.Section1principle......................................

8、................................................................10.第二节关键人员.......................................................................................................10.Section2KeyPersonnel......................