偏差處理案例分析-資料下載頁(yè)
2025-04-16 23:01本頁(yè)面
【正文】 upper seal and FBD bowl rim→ Drinking water was evaporated after drying step but CIP100 residue remained on FBD bowl rim→ Detergent test result out of acceptance criteria出現(xiàn)報(bào)警1383，F(xiàn)BD碗形腔體的上密封圈泄氣 → 飲用水及CIP100進(jìn)入上密封圈和腔體邊緣的縫隙 → 報(bào)警1383 解除，上密封圈重新充氣 → 飲用水及CIP100留在上密封圈和腔體邊緣的空隙中→ 干燥過(guò)程中飲用水蒸發(fā)，但CIP100殘留在腔體邊緣上→ 清潔劑樣品結(jié)果超出接受標(biāo)準(zhǔn)Cause conclusion/原因結(jié)論Abnormal deflate and reinflate of upper seal during drinking water washing/rinse process due to pressed air duct leakage由于壓縮空氣管道漏氣，上密封圈在飲用水清洗/淋洗過(guò)程中發(fā)生了不正常的泄氣并重新充氣Improper/Inadequate handling process for critical GMP alarmsl 關(guān)鍵GMP報(bào)警處理流程不當(dāng)/不足Root Cause/根本原因:During WIP process, alarm 1383 occurred and upper seal of FBD bowl deflated, then drinking water with CIP100 entered the gap between seal and FBD bowl rim. After Alarm 1383 removed (upper seal reinflated) and drying step, CIP100 remained on FBD bowl rim, which finally caused that detergent test result of this sampling point was out of acceptance criteria.WIP過(guò)程中，出現(xiàn)1383報(bào)警，導(dǎo)致這樣修改是否更合適？FBD碗形腔體的上密封圈泄氣，使導(dǎo)致含CIP100的飲用水進(jìn)入上密封圈和腔體邊緣的空隙中。經(jīng)過(guò)報(bào)警1383解除（上密封圈重新充氣）和干燥步驟后，CIP100 殘留在腔體邊緣上，最終導(dǎo)致該取樣點(diǎn)的清潔劑樣品結(jié)果超出接受標(biāo)準(zhǔn)。l Causal Analysis/因果分析: Alarm 1383 occurred and upper seal of FBD bowl deflated → Drinking water with CIP100 entered the gap between seal and FBD bowl rim → Alarm 1383 removed and upper seal reinflated → Drinking water with CIP100 remained in the space between upper seal and FBD bowl rim→ Drinking water was evaporated after drying step but CIP100 residue remained on FBD bowl rim→ Detergent test result out of acceptance criteria出現(xiàn)報(bào)警1383，F(xiàn)BD碗形腔體的上密封圈泄氣 → 含CIP100的飲用水進(jìn)入上密封圈和腔體邊緣的縫隙 → 報(bào)警1383 解除，上密封圈重新充氣 → 飲用水及CIP100留在上密封圈和腔體邊緣的空隙中→ 干燥過(guò)程中飲用水蒸發(fā)，但CIP100殘留在腔體邊緣上→ 清潔劑樣品結(jié)果超出接受標(biāo)準(zhǔn)Follow up action / 后續(xù)行動(dòng)CAPA TW1097877 has been initiated to reduce the risk to manufacturing process/cleaning process resulted from improper/inadequate alarm handling by establishing process on handling critical GMP alarms and updating risk assessment documents.開(kāi)啟CAPA TW1097877：通過(guò)建立關(guān)鍵GMP報(bào)警的處理流程及更新風(fēng)險(xiǎn)評(píng)估文件，來(lái)降低由于報(bào)警處理不當(dāng)/不足而對(duì)生產(chǎn)流程/清潔流程造成影響的風(fēng)險(xiǎn)。Planned actions/計(jì)劃的行動(dòng)A. To update Glatt Granulation equipment risk assessment document (FMEARMPSH2012017) to include the risk of pressed air duct leakage/更新Glatt制粒機(jī)設(shè)備風(fēng)險(xiǎn)評(píng)估文件（FMEARMPSH2012017），加入壓縮空氣管道漏氣的風(fēng)險(xiǎn)As minimum, the pressed air ducts in SHiP plant should be replaced every 5 years. In addition, during annual overhaul, maintenance team will check and assess whether the pressed air ducts should be replaced.SHiP車間的壓縮空氣管道至少每5年更換一次。而且在年度大修時(shí)，機(jī)修團(tuán)隊(duì)會(huì)檢查并評(píng)估壓縮空氣管道是否需要更換。Responsible: Prod, Maintenance team /Chenxi Fu負(fù)責(zé)人：生產(chǎn)部，機(jī)修團(tuán)隊(duì)/傅晨曦B. To update E2E risk assessment documents of Xeloda Tab/Cellcept Cap/Cellcept Tab to include the risk to manufacturing process/cleaning process resulted from improper/inadequate alarm handling/更新希羅達(dá)片劑/驍悉膠囊/驍悉片劑的E2E風(fēng)險(xiǎn)評(píng)估文件，加入由于報(bào)警處理不當(dāng)/不足而對(duì)生產(chǎn)流程/清潔流程造成影響的風(fēng)險(xiǎn)Responsible: Prod, GMP support team /Tony Lu負(fù)責(zé)人：生產(chǎn)部，GMP支持團(tuán)隊(duì)/陸舜堯C. To classify the manufacture equipment alarms, and establish instruction on handling critical GMP alarm/對(duì)制造設(shè)備報(bào)警進(jìn)行分類，建立對(duì)關(guān)鍵GMP報(bào)警誤處理的指導(dǎo)Responsible: Prod, Maintenance team /Chenxi Fu負(fù)責(zé)人：生產(chǎn)部，機(jī)修團(tuán)隊(duì)/傅晨曦Reference/參考Attachment01：Explanation for the principle of alarm 1383 provided by supplier附件01：供應(yīng)商對(duì)1383報(bào)警原理的解釋Completed By/Date 填寫人/日期： 10 / 10
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