偏差处理案例分析资料

1、Causal Analysis Report /因果分析报告Event Description / 事件描述The detergent result of Glatt Granulation train (Sample No.37.2) in cleaning periodic revalidation for Xeloda was out of acceptance criteria.希罗达周期性清洁再验证中，Glatt制粒干燥系统的清洁剂结果（样品编号37.2）超出接受标准。Discrepancy ID number / 差异ID号码TW1079413Causal Analysis Team Participants / 因果分析小组成员Function / 职能Name / 姓名QALily Zhou/周玲洁QVLily Li/李志珍Prod-SMEZhao Bin/赵斌Prod-SMEXu Feng/徐锋Prod-SMEAlex Yu/郁昊MSAT-SMEChen Jie/陈洁Documentation of all information/data available fro

2、m the initial Investigation /初步调查中获取的所有信息/数据的记录1. RCA/因果分析Fishbone diagram /因果分析鱼骨图1.1 Material/物料方面：l Possible cause 1: Citric Acid可能原因1：柠檬酸The supplier for citric acid is not changed since last cleaning validation(2013.01)自从上次清洁验证（2013.01）至今，柠檬酸的供应商未发生过变更。The quantity of citric acid was weighed by two operators and formulation of citric acid solution was performed by two operators. Citric acid solution was pumped into detergent storage container for use. Operator checked the set point of dosin

3、g pump was correct. During WIP process, operator was always beside the detergent storage container and confirmed all citric acid solution was used up. No remark of abnormity was found on logbook.柠檬酸由双人称量，柠檬酸溶液由双人配制。使用前，柠檬酸溶液被吸入清洁剂储罐中待用。员工检查计量泵的设定值正确。在WIP期间，员工始终在清洁剂储罐旁边并确保所有柠檬酸溶液用尽。查看相关日志，没有发现异常情况。Outcome: No.结果：不是可能原因。l Possible cause 2: CIP100可能原因2：CIP100The supplier for CIP100 is not changed since last cleaning validation(2013.01)自从上次清洁验证（2013.01）至今，CIP100的供应商未发生过变更。Two whole drums of CIP100 a

4、re used for WIP. CIP100 is pumped into detergent storage container for use. Operator checked the set point of dosing pump was correct. During WIP process, operator was always beside the detergent storage container and confirmed all CIP100 were used up. No remark of abnormity was found on logbook.两整桶CIP100用于WIP。CIP100被吸入清洁剂储罐中待用。员工检查计量泵的设定值正确。在WIP期间，员工始终在清洁剂储罐旁边并确保所有CIP100用尽。查看相关日志，没有发现异常情况。Outcome: No.结果：不是可能原因。l Possible cause 3: Glove (for cleaning)可能原因3：手套（用于清洁）The supplier for rubber glove i

5、s not changed since last cleaning validation (2013.01)自从上次清洁验证（2013.01）至今，手套的供应商未发生过变更。Rubber glove is single used. 70% Ethanol is only used during gowning before entering granulation room. No 70% ethanol is used during manual cleaning.乳胶手套为一次性使用。只在进入制粒间前的更衣时使用过70% 乙醇。在手工清洁期间没有使用过70% 乙醇。According to current sampling procedure (sop0105674 v2.0), the Sterile glove is used during CV visual inspection form 2015.06.12. Before 2015.06.12, the rubber glove is used during CV visual inspection. The Steri

6、le glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.依据现行版取样程序（sop0105674 v2.0），自2015.06.12起，清洁验证目检时使用无菌手套。在2015.06.12前，清洁验证目检时使用乳胶手套。无菌手套和乳胶手套均为一次性使用，戴手套时不使用70%乙醇。Sterile glove is used during visual inspection and CV sampling after clearance. Sterile glove is single used, and no ethanol is used when wearing sterile glove during visual inspection before CV sampling. 在清场后的目检核清洁验证取样期间使用无菌手套。无菌手套为一次性使用。在清洁验证前的目检期间，戴无菌手套时不使用酒精。According to current sampling procedur

7、e (sop0105674 v2.0), the Sterile glove is used during production visual inspection form 2015.06.12. Before 2015.06.12, the rubber glove is used during production visual inspection. The Sterile glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.依据现行版取样程序（sop0105674 v2.0），自2015.06.12起，生产部在目检样时使用无菌手套。在2015.06.12前，生产部目检时使用乳胶手套。无菌手套和乳胶手套均为一次性使用，戴手套时不使用70% 乙醇。 Above all, interference of 70% ethanol to the detergent result can be excluded. 综上，70%乙醇对酒精对清洁剂结果的干扰可以被排除。Out

8、come: No.结果：不是可能原因。l Possible cause 4: Glove (for Sampling)可能原因4：手套（用于取样）The supplier for glove is not changed since last cleaning validation (2013.01). According to current sampling procedure (sop0105674 v2.0), the Sterile glove is used during visual inspection and TOC sampling form 2015.06.12. Before 2015.06.12, the rubber glove is used during visual inspection and TOC sampling. The Sterile glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.自从上次清洁验证（2013.01）至今

9、，手套的供应商未发生过变更。自2015.06.12起，依据现行版取样程序（sop0105674 v2.0），在目检和TOC取样时使用无菌手套。在2015.06.12前，目检和TOC取样时使用乳胶手套。无菌手套和乳胶手套均为一次性使用，戴手套时不使用70% 乙醇。Outcome: No.结果：不是可能原因。l Possible cause 5: Low fibre wiper可能原因5：低纤维抹布Low fibre wiper is used during manual cleaning for machine and parts. Visual inspection before sampling met the acceptance criteria.低纤维抹布用于设备和部件的手工清洁。取样前的目检结果符合可接受标准。Outcome: No.结果：不是可能原因。l Possible cause 6: Drinking water可能原因6：饮用水The quality monitoring parameters (hardness, chlorine and conductivity) are all within acceptance criteria during clearance according to SRD-0101917 “Operational Log Sheet of SHiP PW system”. And, no abnormal trend for these parameters was found.根据SRD-0101917 SHiP饮用水系统运行记录表”，清场期间的水质监测参数（硬度、余氯和电导率）均在可接受标准内。且没有发现数据有不良趋势。Outcome: No.结果：不是可能原因。l Possible cause 7: Purified water可能原

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