【医药】EU-GMP（共73页）.ppt

GMP  Good Manufacturing Practice （优良的生产实践）药品生产质量管理规范 Seminar for the whole Workforce 职工整体培训 Shanghai Jinji Business Consulting 上海金冀商务咨询有限公司 General Manager 中国地区总经理 Dr. Hartmut Steinel 石泰牛 博士 B.Sc. M.Sc. (University of Ulm, Germany) Ph.D. (University of Sydney, Australia) Nationality: German 国籍 德国 Drafted this seminar 起草该培训资料 GMP Part I Good Manufacturing Practice （优良的生产实践）药品生产质量管理规范 Procedures General Regulations 程序法规概要 G M P “Good Manufacturing Practice” means that a pharmaceutical manufacturer proves that he is in control of all processes involved to manufacture a medicine and can guarantee that the final product complies with all requirements. “国际GMP标准”是所有在西方国家市场上销售药品和医疗器械的强制性生产制造标准。 “（优良的生产实践）药品生产质量管理规范”表示一个制药企业有能力加工某种药品，并且可以保证最终的产品符合所有的要求。 The Manufacturer guarantees 制造商保证成品是 the quality, strength and purity as registered, 质量，浓度，纯度与注册的一致, manufactured, tested, packed and finally assed before release, 放行前已经完成加工，检测，包装和最终评估, and all raw material, intermediates and the finished product have been tested and comply with the registration requirements. 所有的原料，中间体和成品已经进行检测并符合注册要求。 Government Authorities around the world are not satisfied by the word of anybody, they want to make sure that the pharmaceutical manufacturer is able to fulfill his guarantee. 全世界的政府权威部门对任何人的描述都不满意，他们希望确定医药制造商能够履行对于质量的保证。 To insure this guarantee, they have set up regulations for pharmaceutical manufacturers and they are sending inspectors in to check that these regulations are in place and not bypassed. 为了确保质量，他们制定了针对医药制造商的法规，并派遣审查官员检查这些法规的落实。 These inspectors or “auditors” as they are called will issue the GMP license after they have audited a manufacturing facility and have been satisfied that the audited pharmaceutical manufacturer can give the required guarantee. 这些检查员或“审计员”在检查过制造设备，并对提供质量保证满意后颁发GMP证书。 The certificate these auditors give to the pharmaceutical manufacturer is valid for 2 years. The auditors will return after 2 years, or if the