【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出現報警1383，FBD碗形腔體的上密封圈泄氣 → 飲用水及CIP100進入上密封圈和腔體邊緣的縫隙 → 報警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→ 干燥過程中飲用水蒸發(fā)，但CIP100殘留在腔體邊緣上→ 清潔劑樣品結果超出接受標準Cause conclusion/原因結論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 關鍵GMP報警處理流程不當/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過程中，出現1383報警，導致這樣修改是否更合適？FBD碗形腔體的上密封圈泄氣，使導致含CIP100的飲用水進入上密封圈和腔體邊緣的空隙中。經過報警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，最終導致該取樣點的清潔劑樣品結果超出接受標準。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出現報警1383，FBD碗形腔體的上密封圈泄氣 → 含CIP100的飲用水進入上密封圈和腔體邊緣的縫隙 → 報警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→ 干燥過程中飲用水蒸發(fā)，但CIP100殘留在腔體邊緣上→ 清潔劑樣品結果超出接受標準Follow up action / 后續(xù)行動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.開啟CAPA TW1097877：通過建立關鍵GMP報警的處理流程及更新風險評估文件，來降低由于報警處理不當/不足而對生產流程/清潔流程造成影響的風險。Planned actions/計劃的行動A. To update Glatt Granulation equipment risk assessment document (FMEARMPSH2012017) to include the risk of pressed air duct leakage/更新Glatt制粒機設備風險評估文件（FMEARMPSH2012017），加入壓縮空氣管道漏氣的風險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，機修團隊會檢查并評估壓縮空氣管道是否需要更換。Responsible: Prod, Maintenance team /Chenxi Fu負責人：生產部，機修團隊/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/更新希羅達片劑/驍悉膠囊/驍悉片劑的E2E風險評估文件，加入由于報警處理不當/不足而對生產流程/清潔流程造成影響的風險Responsible: Prod, GMP support team /Tony Lu負責人：生產部，GMP支持團隊/陸舜堯C. To classify the manufacture equipment alarms, and establish instruction on handling critical GMP alarm/對制造設備報警進行分類，建立對關鍵GMP報警誤處理的指導Responsible: Prod, Maintenance team /Chenxi Fu負責人：生產部，機修團隊/傅晨曦Reference/參考Attachment01：Explanation for the principle of alarm 1383 provided by supplier附件01：供應商對1383報警原理的解釋Completed By/Date 填寫人/日期： 10 / 10