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歐盟清潔驗證方案-閱讀頁

2024-08-29 21:41本頁面
  

【正文】 ient清潔方法不足夠有效 Ditto同上Ditto同上Ditto同上Ditto同上Check cleaning result at defined location在規(guī)定部位檢查清潔結果Ditto同上Ditto同上Ditto同上Ditto同上See validation protocol 見清潔驗證方案 * Sample No. see five sampling points on Table 4. 取樣部位:共5個取樣點見表4.Attachment附件3: Risk Analysis Table for active ingredient風險分析表:FormatA+B Equipment Name 設備名稱: Korsch PH30036 Tablet Press Date日期: KORSCH PH30036旋轉式壓片機1234*Critical關鍵Risk for Process Step風險 Eval.of risk風險評估Followupof risk是否確認為有風險Possible cause可能的原因Validation measur驗證措施Validation plan驗證計劃Date日期Responsible person負責人No.序號ComponentName部件名稱Sam. No.取樣部位Contact Area藥品接觸表面Yes是No否Yes是No否12345678Hopper 下料斗飼料靴出片器除粉器壓片室隔板轉盤沖頭和沖模??譏nner surface內表面表面及孔表面內表面表面表面內表面內表面XXXXXXXXPossibility of contamination with previous product與前批產品交叉污染的可能性Ditto同上Ditto同上 Ditto同上MHM MLMLHxxxxxxxxCleaning procedure of SOP is not efficient清潔方法不足夠有效Ditto同上Ditto同上Ditto同上 Ditto同上 Check cleaning result at defined location在規(guī)定部位檢查清潔結果Ditto同上Ditto同上Ditto同上 Ditto同上See validation protocol 見清潔驗證方案* Sample No. see the eight sampling points on Table5. 取樣部位: 共8個取樣點見表5.Attachment附件4: Risk Analysis Table for active ingredient風險分析表:FormatA+B Equipment Name 設備名稱: Three-dimensional mixer Date日期: HLD1000B型料斗式混合機清潔操作規(guī)程1234*Critical關鍵Risk for Process Step風險 Eval.of risk風險評估Followupof risk是否確認為有風險Possible cause可能的原因Validation measur驗證措施Validation plan驗證計劃Date日期Responsible person負責人No.序號ComponentName部件名稱Sam. No.取樣部位Contact Area藥品接觸表面Yes是No否Yes是No否123加料口出料口腔體Inner surface內表面Inner surface內表面Inner surface內表面XXXPossibility of contamination with previous product與前批產品交叉污染的可能性Ditto同上MMH xxxCleaning procedure of SOP is not efficient清潔方法不足夠有效Ditto同上Ditto同上 Check cleaning result at defined location在規(guī)定部位檢查清潔結果Ditto同上Ditto同上See validation protocol 見清潔驗證方案* Sample No. see the three sampling points on Table 6. 取樣部位: 共3個取樣點見表6.Attachment附件5: Risk Analysis Table for active ingredient風險分析表:FormatA+B Equipment Name 設備名稱: CTC2 Hot Air Circulating Drier Date日期: CTC2型熱風循環(huán)烘箱1234*Critical關鍵Risk for Process Step風險 Eval.of risk風險評估Followupof risk是否確認為有風險Possible cause可能的原因Validation measur驗證措施Validation plan驗證計劃Date日期Responsible person負責人No.序號ComponentName部件名稱Sam. No.取樣部位Contact Area藥品接觸表面Yes是No否Yes是No否1234烘盤箱體臺車箱門Surface表面Inner surface內表面Surface 表面Inner surface內表面XXXXPossibility of contamination with previous product與前批產品交叉污染的可能性Ditto同上Ditto同上 Ditto同上MHM H xxxxCleaning procedure of SOP is not efficient清潔方法不足夠有效Ditto同上Ditto同上Ditto同上 Check cleaning result at defined location在規(guī)定部位檢查清潔結果Ditto同上Ditto同上Ditto同上 See validation protocol 見清潔驗證方案* Sample No. see the ten sampling points on Table 7. 取樣部位: 共10個取樣點見表7.
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