中国GMP（中英对照版）.docx

Chinese GMPOfficial TranslationThese provisions will be implemented from March 1st, 2011. Detailed implementation plan will be published by SFDA according to article 9 in Drug Administration Law of the People’s Republic of China第一章　总　则Chapter [t??pt?(r)] 1 General [d?enr?l] provisions [pr?v??n]第二章　质量管理Chapter 2 Quality management第一节　原　则Section 1 Principle [prins?pl]第二节　质量保证Section 2 Quality Assurance第三节　质量控制Section 3 Quality Control第四节　质量风险管理Section 4 Quality risk management第三章　机构与人员Chapter 3 Organization [??:g?na??ze??n] and personnel [?p?:s??nel]第一节　原　则Section 1 Principle [?pr?ns?pl]第二节　关键人员Section 2 Key personnel [?p?:s??nel] 第三节　培　训Section 3 Training第四节　人员卫生Section 4 Personnel hygiene [?ha?d?i:n]第四章　厂房与设施Chapter4 Premises [?prem?s?z] and facilities [f?s?l?t?z]第一节　原　则Section 1 Principle[prins?pl]第二节　生产区Section 2 Production area第三节　仓储区Section 3 Storage areas第四节　质量控制区Section 4 Quality control areas第五节　成　品Section 5 Finished products第五章　设　备Chapter 5 Equipment第一节　原　则Section 1 Principle第二节　设计和安装Section 2 Design and installation第三节　维护和维修Section 3 Maintenance [me?nt(?)n?ns] and repair第四节　使用和清洁Section 4 Usage and cleaning第五节　校　准Section 5 Calibration [k?l?bre??(?)n]第六节　制药用水Section 6 Water for pharmaceutical [,fɑrm?sut?kl] use第六章　物料与产品Chapter 6 Materials [m?t??r??lz] and products第一节　原　则Section 1 Principle第二节　原辅料Section 2 Starting materials [m?t??r??lz]第三节 中间产品和待包装产品Section 3 Intermediate [,?nt?mi?d??t] and bulk [b?lk] products第四节　包装材料Section 4 Packaging materials [m?t??r??lz]第五节　成　品Section 5 Finished products第六节　特殊管理的物料和产品Section 6 Controlled materials and products第七节　其　他Section 7 Others第七章　确认与验证Chapter 7 Qualification [,kw?l?f?ke??(?)n] and validation [,v?l?de???n]第八章　文件管理Chapter 8 Documentation [,d?kj?mente??(?)n]第一节　原　则Section 1 Principle [pr?ns?p(?)l]第二节　质量标准Section 2 Specifications [,sp?s?f?ke??nz]第三节　工艺规程Section 3 Master formulae [f??mj?li?]第四节　批生产记录Section 4 Batch [b?t?] processing records第五节　批包装记录Section 5 Batch packaging record第六节　操作规程和记录Section 6 Operating proced