计算机化系统及CSV-DI培训课件.pptx

计算机化系统及CSV,DI培训1 内容401/02/03/ GAMP 5基于风险的计算机化系统验证CSV基础架构确认GMP相关重点概念解析04/ 系统验证状态保持及运维管理 1重点概念解析5 6重点概念解析1432确认与验证的区别计算机系统和计算机化系统的区别审计追踪和系统日志的区别计算机化系统验证和质量体系、质量风险管理的关联 7确认与验证的区别MNPA 2010版品生产质量管理规范---定义确认证明厂房、设施、设备能正确运行并可达到预期结果的一系列活动。验证证明任何操作规程（或方法）、生产工艺或系统能够达到预期结果的一系列活动。确认和验证的本质区别在于对象不同验证针对的是流程，确认针对的是单个系统人员的资质通常用确认（Qualifications）对象---目标---方法和手段，采用三段论的方法去分析确认 验证厂房确认 工艺验证公用系统确认 清洁验证工艺设备确认 方法验证分析设备确认 计算机化系统验证 8确认与验证的区别FDA Guidance for Industry Quality System Approach to Pharmaceutical cGMP Regulations 2006-09Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.Verification---核实Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. 验证-核实-确认Validation---验证 9确认与验证的区别PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01Process ValidationThe documented evidence that the process, operated within established parameters, can performeffectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.Cleaning ValidationThe gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.PIC/S系列定义 10确认与验证的区别PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01Concurrent ValidationValidation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialization of the validation batches.Prospective ValidationValidation carried out before routine production of products intended for sale.PIC/S系列定义 11确认与验证的区别EU Annex 11 Computerized System 2011-06-30The application should be validated; IT infrastructure should be qualified.应用需要被验证，基础架构需要被确认第六条计算机化系统验证包括应用程序的验证和基础架构的确认，其范围与程度应当基于科学的风险评估。风险评估应当充分考虑计算机化系统的使用范围