欧美风险评估办法在生物制剂车间中应用.PDF

欧美风险评估办法在生物制剂车间中的应用 --系统影响评估/关键组件分析 马义岭 2011-6-20 Austar Promotes Industry Advancement Contents 内容 • Risk Assessment and Regulation 风险分析及相关法规 • 系统影响评估 System Impact Assessment(SIA) • 关键组件分析CCA Critical Component Assessment(CCA) .hk Risk Assessment and Regulation • 欧盟药品质量管理规范— 附录20 质量风险管理. EU Guidelines to Good Manufacturing Practice - Annex 20 Quality Risk Management • ISPE指南第五卷“调试和验证”. ISPE Baseline guide Volume 5 commissioning and qualification • ICH质量风险管理三方协调指导原则Q9，附录1，2 ICH Harmonized Tripartite Guideline Quality Risk Management Q9, Annex I, 2 • ASTM E2500-07制药和生物制药生产系统和设备的技术说明、设计 和验证标准指南。 ASTM E2500-07 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. .hk Risk Assessment and Regulation .hk Risk Assessment and Regulation .hk System Impact Assessment(SIA) 系统影响性评估（SIA ）：评估系统的运行、控制、报警和故障状况对产品质 量的影响的过程。 System Impact Assessment (SIA): The process of evaluating the impact of the operating, controlling, alarming, and failure conditions of a system on the quality of a product. 系统影响性评估将系统分为三类，即直接影响系统、间接影响系统和无影响系 统。 The impact assessment will be classified the system into three categories， such as direct impact system, indirect impact system and no impact system. 在进行影响评估时，将根据7个问题对各设备/系统进行评估。对于任何一个 设备/系统，7个问题中只要有一个问题的答案是“Yes”，就将该设备/系统归类 为直接影响的系统。 Impact of a equipment/system will be assessed according to the following 7 questions. For any equipment/system, if the answer is “yes” to any of the 7 questions, the component is classified as direct impact system. .hk System Impact Assessment(SIA) 1. Does the system have direct contact with the