2017GMP简述

GMP,Good Manufacturing Practice （优良的生产实践）药品生产质量管理规范,目录,GMP,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。,GMP来源,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,GMP对质量管理部门赋予权威，与质量有关的文件都要由质量管理部门审核、批准。GMP要求贯穿整个生产过程的严格、详细的文件：比如操作人员动作文件化指定发放中间体的人员,记录,所有有关产品质量的活动都应被记录。任何偏离文件的情况都应有文字记录并加以解释。对关键性的偏差进行调查，记录调查经过及结果，分析原因，并制定预防整改措施记录应确保清楚、准确、可追溯，关键数字的修改应注明原因并经过批准。,验证,以数据说话，与质量有关的计量器具需经校验合格后方可使用。生产、检验、物流全过程都需要经过验证审评，有充分的数据支持，验证方法符合相关指南如清洁验证指南洁净区环境监测方法等。每年进行质量回顾，根据评估结果制定措施如今后的行动线（OOT值）。,Clean,The most important is Clean. All