11下午培训.pptxVIP

Equipment and Facility Qualification /设备和设施的验证Main content /主要内容Introduction / 导言Project management / 项目管理Validation / Qualification Master Plan /VMPUser requirement specification /URSDesign qualification / DQInstallation Qualification /IQOperational Qualification/OQPerformance Qualification/PQDocumentation System / 文件系统Change Control / 变更控制 I INTRODUCTIONThe important of qualification process of technical system in the pharmaceutical industry has been steadily increasing over the last 10 years./在过去的１０年中最重要的技术体系的验证工艺一直在稳步增加。It has been driven primarily by the regulatory bodies and not by the need to save money in this part of the industry./　起初是因为监管部门的作用，而不是需要省钱在制药业。continueIf the industry made use of the full scope of GMP requirement, the qualification process would be more efficient and cost of qualification would drop./　如果制药业使用的全范围的GMP要求，验证将是提高效率和减低成本。On the other hand, pharmaceutical companies want to protect themselves from less than perfect result during a regulatory inspection and therefore demand 120% effort from their suppliers and service companies. /另一方面，制药公司希望能够在监督审查过程保护自己，因此要求们的供应商和服务公司对他们产品复出120 ％的努力New methods and tools must be implemented to reach the goal of qualifying a technical system while minimizing effort./新的方法和工具必须得到执行，以达到目标的合格的技术体系，同时尽量减少工作Another aspect is trend for quality assurance departments to evolve from being mere controllers of product quality to delivering tools and methods to other departments, thus helping them to design a better production process./另一个方面质量保证部门演变成为向其他部门提供单纯的控制器产品质量提供工具和方法的发展趋势，从而帮助他们设计一个更好的生产过程。Qualification and validation only appear to be the beginning of a continuous development process in the quality assurance of the pharmaceutical industry.验证成为确保制药业质量保证可持续发展过程中的唯一方法To avoid misunderstanding, it is crucial to use the correct terms and expressions during quality management. A list of definition can be found in the appropriate section.为了避免误解，关键的是要使用正确的用词和用语中的质量管理。特定的词语定义可以在缩写词语的清单中找到。The following describes how