偏差處理案例分析(已修改)
2025-04-28 23:01 本頁(yè)面
【正文】 Causal Analysis Report /因果分析報(bào)告Event Description / 事件描述The detergent result of Glatt Granulation train (Sample ) in cleaning periodic revalidation for Xeloda was out of acceptance criteria.希羅達(dá)周期性清潔再驗(yàn)證中，Glatt制粒干燥系統(tǒng)的清潔劑結(jié)果（）超出接受標(biāo)準(zhǔn)。Discrepancy ID number / 差異ID號(hào)碼TW1079413Causal Analysis Team Participants / 因果分析小組成員Function / 職能Name / 姓名QALily Zhou/周玲潔QVLily Li/李志珍ProdSMEZhao Bin/趙斌ProdSMEXu Feng/徐鋒ProdSMEAlex Yu/郁昊MSATSMEChen Jie/陳潔Documentation of all information/data available from the initial Investigation /初步調(diào)查中獲取的所有信息/數(shù)據(jù)的記錄1. RCA/因果分析—Fishbone diagram /因果分析——魚(yú)骨圖 Material/物料方面：l Possible cause 1: Citric Acid可能原因1：檸檬酸The supplier for citric acid is not changed since last cleaning validation()自從上次清潔驗(yàn)證（）至今，檸檬酸的供應(yīng)商未發(fā)生過(guò)變更。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 dosing 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.檸檬酸由雙人稱量，檸檬酸溶液由雙人配制。使用前，檸檬酸溶液被吸入清潔劑儲(chǔ)罐中待用。員工檢查計(jì)量泵的設(shè)定值正確。在WIP期間，員工始終在清潔劑儲(chǔ)罐旁邊并確保所有檸檬酸溶液用盡。查看相關(guān)日志，沒(méi)有發(fā)現(xiàn)異常情況。Oute: No.結(jié)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()自從上次清潔驗(yàn)證（）至今，CIP100的供應(yīng)商未發(fā)生過(guò)變更。Two whole drums of CIP100 are 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.兩整桶CIP100用于WIP。CIP100被吸入清潔劑儲(chǔ)罐中待用。員工檢查計(jì)量泵的設(shè)定值正確。在WIP期間，員工始終在清潔劑儲(chǔ)罐旁邊并確保所有CIP100用盡。查看相關(guān)日志，沒(méi)有發(fā)現(xiàn)異常情況。Oute: No.結(jié)果：不是可能原因。l Possible cause 3: Glove (for cleaning)可能原因3：手套（用于清潔）The supplier for rubber glove is not changed since last cleaning validation ()自從上次清潔驗(yàn)證（）至今，手套的供應(yīng)商未發(fā)生過(guò)變更。Rubber glove is single used. 70% Ethanol is only used during gowning before entering granulation room. No 70% ethanol is used during manual cleaning.乳膠手套為一次性使用。只在進(jìn)入制粒間前的更衣時(shí)使用過(guò)70% 乙醇。在手工清潔期間沒(méi)有使用過(guò)70% 乙醇。According to current sampling procedure (sop0105674 ), the Sterile glove is used during CV visual inspection form . Before , the rubber glove is used during CV visual inspection. The Sterile glove and rubber glove is single used, and no 70% ethanol is used when wearing glove.依據(jù)現(xiàn)行版取樣程序（sop0105674 ），清潔驗(yàn)證目檢時(shí)使用無(wú)菌手套。，清潔驗(yàn)證目檢時(shí)使用乳膠手套。無(wú)菌手套和乳膠手套均為一次性使用，戴手套時(shí)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. 在清場(chǎng)后的目檢核清潔驗(yàn)證取樣期間使用無(wú)菌手套。無(wú)菌手套為一次性使用。在清潔驗(yàn)證前的目檢期間，戴無(wú)菌手套時(shí)不使用酒精。According to current sampling procedure (sop0105674 ), the Sterile glove is used during production visual inspection form . Before , 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.依據(jù)現(xiàn)行版取樣程序（sop0105674 ），生產(chǎn)部在目檢樣時(shí)
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