EU-GMP欧盟药品生产质量管理规范.ppt

GMP ;Shanghai Jinji Business Consulting 上海金冀商务咨询有限公司 ;GMP Part I; 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; 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 there is a major complaint. 该证书的有效期为2年，检查官会在2年后重新检查，或者当出现投诉的时候复查。 This certificate is called GMP license. 这就是GMP证书。; Now, every pharmaceutical manufacturer in the Peoples Republic of China has a GMP license from the Chinese SFDA. Therefore, there is no need to continue this presentation, 现在，每一家中国的制药企业都已经通过中国SFDA的检查并获得证书。因此，没有必要持续现状。 except, if you want to sell your products outside of China. 除非，您只希望在中国范围内销售您的产品。; To sell pharmaceutical products outside of China your sponsor or agent in the foreign country has to contact the inspection agency of his area and ask for an inspection of your Chinese factory。For Yangtze Group we will use Chem Swiss AG and the GMP certificate w