GMP（优良的生产实践）药品生产质量管理规范.pptxVIP

GMP ;目录; 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. “GMP标准”是所有在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。 ; 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??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。; TheGMP license is like a drivers license. GMP证书就象一张驾照。 It is completely irrelevant if you can drive or not. Without a license you are not allowed to drive. 这不是您可不可以驾驶的问题。而是没有这张驾照在法律上就意味着不允许驾驶。 ;G M P要求企业建立 工程设备系统 质量管理系统 实验室控制系统 物料管理系统 生产管理系统 卫生管理系统 组成的质量体系来防止生产过程存在污染、交叉污染、混淆和差错等风险。;文件;记录;验证;Clean;谢谢！