蒸汽灭菌和冻干工艺的验证及风险分析 翻译版-CTP Giuseppe Ruggirello.ppt

ICH Q9 HARM: Damage to health, including the damage that can occur from loss of product quality or availability 危害：对健康造成伤害，它可以是产品质量或药效缺所致的损害。 HAZARD: Potential source of harm 危险：可能造成危害的因素 SEVERITY: Measure of the possible consequences of a hazard 严重性：危险可造成后果的严重程度 ICH Q9 DEFINITIONS 定义 PROBABILITY: Extent to which the harm is likely to occur 概率：指危害可能发生的几率 RISK : Combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51) 风险：指危害发生概率及严重程度的综合结果(ISO/IEC Guide 51) DETECTABILITY: Extent to which the harm is evident 可检测性：指危害可明显察觉/查出的程度 RISK ANALYSIS: Use of available information to identify hazards and to estimate the risk 风险分析：通过现有信息来识别危害并对风险进行评估 质量风险管理的过程QUALITY RISK MANAGEMENT PROCESS 质量风险管理的过程QRM PROCESS 风险管理程序的启动 为鉴别潜在的风险，要界定问题/风险，包括相关的假设 综合与风险评估相关的背景信息和/或数据，包括潜在的危险、危害或对人体健康的影响 识别主要风险及其关键来源 列出风险管理流程决定的适当水平，进度表及可递交的文件 风险控制 Risk Control 风险降低+风险可接受度 包括制定降低风险或接受风险的决策 风险控制的目的是使风险降低到可接受的程度 风险控制所投入的精力应与风险的重要性成一定比例 决策者通过多种方法了解风险控制的最佳水平，包括成本效益分析 1. 上述风险是否可被接受? 2. 降低、控制或消除风险需要做什么？ 3.在资源投放、收益及风险之间，是否有适当的平衡？ 4.已确定风险的控制是否会导致新的风险？ 失败模式及影响分析结果评估 FMEA sterilization 鉴别原因和影响-1 灭菌柜确认的鉴别试验 示例: 产品的无菌缺陷 示例: 湿产品 示例：包装损坏 * It is checked that 6 patient deceases in the incident * 中间一段的原文意思不明确。 如3项各是9，可得到3x9=27； Identification Test for Autoclave Qualification * * * * * RISK ASSESSMENT RISK CONTROL RISK REVIEW Failure Cause Effect S P R PRI Operative Verification FAT SAT IQ OQ S P R IPR Loss of data in report Wrong configuration of the system Incomplete documentation 3 2 2 12 Verification of saved data X 3 2 1 6 Validation of installed new report Data not available Saving of data not working properly Loss of data 3 1 3 9 Verification of saved data X 3 1 1 3 No further action is required Data not available Back-up Restore not working properly Loss of data 3 1 3 9 Verification of back-up Restore functionality X 3 1 2 6 Periodic review of control system Data not available Back up restore non described in an SOP Loss of data 2 3 3 18 Verification of SO