有效的偏差调和纠偏预防体系.pptVIP

有效的偏差调查和纠偏预防体系 偏差定义、分类 Departure from an approved procedure, instruction or established standard. Material abnormality and OOS are out of scope. 偏差：是指对批准的程序、指令或建立的标准的偏离。异常物料和OOS不在此范畴 Deviations should be categorized difference level according to their severity and impact on product quality and/or non-conformance with a GMP standard 3级偏差：对GMP或程序的偏离，不会对产品的质量造成影响的偏差。 2级偏差：对于批准的规程或工艺的偏差，通常需要立刻采取或建立纠偏措施加以解决。2级偏差也可以由于一系列重复的L3偏差导致。 1级偏差：可能对产品的质量（如纯度和特性）、安全性、有效性等产生实际的或潜在的不良影响的偏差。L1偏差也可以由于一系列重复的2级偏差导致 12级偏差必须有完善的调查和纠偏预防措施，3级偏差需要分析和记录 AZ偏差系统包括3种：偏差系统、OOS、异常物料 偏差风险评估 偏差调查责任表 偏差十步调查法 发现偏差 立即采取行动 偏差分类并记录 展开调查 定义调查的范围 组建调查队伍 偏差原因确定 制定纠偏预防措施 纠偏措施的实施和预防措施的跟进 涉及产品批的处理 偏差描述关键点 Focus on facts – not emotions描述事实，不要带情感 what is wrong, not why it’s wrong State the problem in measurable terms 用衡量性指标界定问题 when, where, who, how often, how much Emphasize the Risk, such as safety,efficacy 强调风险 Avoid 要避免： negative descriptors, inflammatory statements 负面煽动性描述 words that are broad and do not describe the conditions or behavior such as careless, complacency, neglect, oversight 语言空洞，避免描述情况或行为像不小心、疏忽等 偏差调查关键点 Ultimate goal - determine WHY the problem occurred 发现问题根源 Not all root cause can be found, the most possible cause should be found at least 至少要了解最可能的根源 A cross-function work, expert in different area are involved 团队合作，专家介入 Investigation Tools are used: Fish-bone 鱼骨图 纠偏预防关键点 Identify the CAPA according to the investigation result 纠偏预防措施必须与调查结果匹配 Risk analysis and prioritization is suitable also 运用风险评估＆优先措施 The product related action must be included in CA 纠偏措施必须包括对产品的处理 CA should be finished before batch disposition 纠偏措施必须在批处理之前完成 PA should be planned and agreed with responsible area. 预防措施必须征得责任方同意 “不完美”的纠偏预防体系 Recurring issues 同样问题反复发生 Inability to “manage” the many sources of quality data to understand early trends and issues 缺乏分析质量数据的能力，无法发现问题的苗头 More reaction than prevention 被动而非主动 Resources ($$$) are spent on “handling” failure rather