偏差處理案例分析-展示頁
2025-04-25 23:01本頁面
【正文】 d for these parameters根據(jù)SHiP純水系統(tǒng)的打印記錄，清場期間的水質(zhì)監(jiān)測參數(shù)（臭氧和電導(dǎo)率）均在可接受范圍內(nèi)。且沒有發(fā)現(xiàn)數(shù)據(jù)有不良趨勢。Oute: No.結(jié)果：不是可能原因。l Possible cause 5: Low fibre wiper可能原因5：低纖維抹布Low fibre wiper is used during manual cleaning for machine and parts. Visual inspection before sampling met the acceptance criteria.低纖維抹布用于設(shè)備和部件的手工清潔。無菌手套和乳膠手套均為一次性使用，戴手套時不使用70% 乙醇。依據(jù)現(xiàn)行版取樣程序（sop0105674 ），在目檢和TOC取樣時使用無菌手套。Oute: No.結(jié)果：不是可能原因。無菌手套和乳膠手套均為一次性使用，戴手套時不使用70% 乙醇。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)部在目檢樣時使用無菌手套。無菌手套為一次性使用。乙醇。清潔驗證目檢時使用乳膠手套。在手工清潔期間沒有使用過70% 乙醇。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。Oute: No.結(jié)果：不是可能原因。在WIP期間，員工始終在清潔劑儲罐旁邊并確保所有CIP100用盡。CIP100被吸入清潔劑儲罐中待用。l Possible cause 2: CIP100可能原因2：CIP100The supplier for CIP100 is not changed since last cleaning validation()自從上次清潔驗證（）至今，CIP100的供應(yīng)商未發(fā)生過變更。查看相關(guān)日志，沒有發(fā)現(xiàn)異常情況。員工檢查計量泵的設(shè)定值正確。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。Causal Analysis Report /因果分析報告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()自從上次清潔驗證（）至今，檸檬酸的供應(yīng)商未發(fā)生過變更。使用前，檸檬酸溶液被吸入清潔劑儲罐中待用。在WIP期間，員工始終在清潔劑儲罐旁邊并確保所有檸檬酸溶液用盡。Oute: No.結(jié)果：不是可能原因。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。員工檢查計量泵的設(shè)定值正確。查看相關(guān)日志，沒有發(fā)現(xiàn)異常情況。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 ()自從上次清潔驗證（）至今，手套的供應(yīng)商未發(fā)生過變更。只在進(jìn)入制粒間前的更衣時使用過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 vis
教學(xué)教案相關(guān)推薦
鄂ICP備17016276號-1