试论《良好自动化生产实践指南(第5版)》指导下药品生产与流通企业计算机化系统的验证  

Discussion on the Computerized System Validation of Drug Production and Distribution Enterprises under the Guidance of Good Automated Manufacturing Practice(5th Edition)

作　　者：梁毅[1] 焦蒙[1] 

机构地区：[1]中国药科大学国际医药商学院,南京210009

出　　处：《中国药房》2015年第13期1736-1739,共4页China Pharmacy

摘　　要：目的:基于《良好自动化生产实践指南(第5版)》(GAMP 5)框架下的5个基本要素,探讨药品生产与流通企业中计算机化系统的验证。方法:在GAMP 5的指导原则下,介绍计算机化系统的概念和分类,分析计算机化系统验证的普遍情况与特殊情况、必要性、监管需求,并对质量风险管理的原理与方法在计算机化系统验证的生命周期的各个阶段进行阐述。结果:由操作系统、不可配置组件、可配置组件与定制组件4个主要部分构成的计算机化系统,其生命周期由概念提出、项目实施、系统运行、系统退役4个阶段构成,验证分为设计确认、安装确认、运行确认和性能确认4个环节。质量风险管理在GAMP 5中体现在其沿用了人用药物注册技术要求国际协调会(ICH)Q9中提出的质量风险管理原则。结论:GAMP 5指导下的计算机化系统验证,可证明该系统能符合《药品生产质量管理规范》等各项法规和预定用途,确保系统运行稳定可靠。OBJECTIVE： To discuss the computerized system validation of drug production and distribution enterprises based on the 5 basic elements within the framework of Good Automated Manufacturing Practice （5th Edition） （GAMP 5）. METHODS： Under the guidance of GAMP 5, the concept and classification of the computerized system were introduced, the generality, particu- larity, necessity and the regulatory requirements for computerized system validation were analyzed and the principles and methods of quality risk management in each stage of life cycle of computerized system were described. RESULTS： The computerized system mainly consisted of oPerating system, non-configurable components, configurable components and customized components, It had a life cycle of 4 stages （concept proposing, project implementation, system operation and system decommission）, and the verifica- tion of the system included design validation, installation validation, operation validation and performance validation. The quality risk management in GAMP 5 was reflected by the application of the quality risk management principles in the Q9 issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH）. CONCLUSIONS： The computerized system validation under the guidance of GAMP 5 can prove that the system conforms to the Good Manufacture Practice of Drugs and other regulations and ensure stable and reliable system operation.

关 键 词：良好自动化生产实践指南 药品生产与流通企业 计算机化系统 验证 

分 类 号：R95[医药卫生—药学]