季铁军-水泡眼机验证风险评估.ppt

* 设备确认中的风险评估 ----如何确定确认项目 季铁军 * 设备确认流程 GMP GEP 产品URS 工艺流程图/工艺信息 确认计划O = Occurrence D = Detection Risk = OxDxS IQ OQ PQ PV CIA DQ (incl. in QP) 安全 能力 可操作性 工程设计及建造 技术标准 供应商测试文件 供应商选择 供应商测试文件 供应商测试文件 设备供应商 安装及测试 确认过程延伸 SOPs 工艺流程 风险分析 * 案例分析: 水泡眼包装线产品URS GMP 要求 内包装区域需要洁净环境 1个完整水泡眼中有1粒药片 产品包括所有患者须知信息 可变信息清晰 药片不会在包装过程中损坏或污染 * 案例分析: 水泡眼包装线风险评估 用户需求：1个完整水泡眼中有1粒药片 可能风险 部分成型的泡罩 没有泡罩形成 片子损坏 在水泡眼中存在多个片子 空水泡眼 其他产品混入 * 潜在风险 S Severity O Occurrence 改善行动 D Detect ability RPN Risk Profile Number 部分成型的泡罩 5 1 SOP-装机流程 照相系统 3 15 没有泡罩形成 5 1 SOP-装机流程 照相系统 3 15 片子损坏 5 8 照相系统 2 80 1 药片 5 8 照相系统 2 80 空水泡眼 5 8 照相系统 1 40 其他产品混入 9 4 照相系统 2 72 案例分析: 水泡眼包装线 （FMEA）风险评估，改善及改善后风险 * 风险优先数 = 风险 x 频率 x 可发现性 0 RPN 70 记录试机的合理性 试机测试结果 70 RPN 100 专门的确认试验 100 RPN 不可接受，需要重新改善或设计 加入严重性 = 9 专门的确认试验 US Quality Risk Management Seminar name * * This slide shows the proposed process for the qualification of direct impact systems. It should be noted that the starting point for the process is the URS for the product. The present process is ‘feed back’ i.e. from analysis of the equipment we consider the effect on the product. The proposed process is ‘feed forward’ it starts by analysing ‘threats’ to the product quality and the effect to the patient and feeds forward controls into the equipment specification. The process map and information is a high level description of the actions and operations to be carried out by the system being considered. A risk assessment is carried out for each of the GMP product attributes defined in the URS. Faults in the end product are identified together with a severity rating the fault would have on the patient. Controls are identified for the faults and these are designated either ‘soft’ being procedural controls or ‘hard’ being equipment hardware controls. Where hard controls are identified the requirement for these is carried forward into the technical specification to the supplier for purchase. The qualification plan is a working summary