【正文】 tto同上 Check cleaning result at defined location在規(guī)定部位檢查清潔結(jié)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(fēng)險分析表:FormatA+B Equipment Name 設(shè)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(guān)鍵Risk for Process Step風(fēng)險 Eval.of risk風(fēng)險評估Followupof risk是否確認(rèn)為有風(fēng)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(fù)責(zé)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(nèi)表面Inner surface內(nèi)表面Inner surface內(nèi)表面XXXPossibility of contamination with previous product與前批產(chǎn)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(jié)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(fēng)險分析表:FormatA+B Equipment Name 設(shè)備名稱: CTC2 Hot Air Circulating Drier Date日期: CTC2型熱風(fēng)循環(huán)烘箱1234*Critical關(guān)鍵Risk for Process Step風(fēng)險 Eval.of risk風(fēng)險評估Followupof risk是否確認(rèn)為有風(fēng)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(fù)責(zé)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(nèi)表面Surface 表面Inner surface內(nèi)表面XXXXPossibility of contamination with previous product與前批產(chǎn)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(jié)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.Attachment附件6: Risk Analysis Table for active ingredient風(fēng)險分析表:FormatA+B Equipment Name 設(shè)備名稱: JZF400 granulators amp。驗證研究包括主要表面積和難清潔部位的擦拭。對活性成分擦拭取樣和淋洗水取樣。 mill Date日期: JZF400型整粒、粉碎機1234*Critical關(guān)鍵Risk for Process Step風(fēng)險 Eval.of risk風(fēng)險評估Followupof risk是否確認(rèn)為有風(fēng)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(fù)責(zé)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12345篩網(wǎng)斗和篩網(wǎng)葉輪料斗、料斗蓋XXXXXPossibility of contamination with previous product與前批產(chǎn)品交叉污染的可能性Ditto同上Ditto同上 Ditto同上MHM H HxxxxxCleaning 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(jié)果Ditto同上Ditto同上Ditto同上 Ditto同上See validation protocol 見清潔驗證方案 QA * Sample No. see the six sampling points on Table 8. 取樣部位： 共6個取樣點見表8.Attachment附件7: Risk Analysis Table for active ingredient風(fēng)險分析表:FormatA+B Equipment Name 設(shè)備名稱: DPP250B blister packaging machine Date日期: DPP250B型多功能自動鋁塑包裝機1234*Critical關(guān)鍵Risk for Process Step風(fēng)險 Eval.of risk風(fēng)險評估Followupof risk是否確認(rèn)為有風(fēng)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(fù)責(zé)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加料斗分料刷滾刷Inner surface內(nèi)表面Surface 表面Surface 表面XXXPossibility of contamination with previous product與前批產(chǎn)品交叉污染的可能性Ditto同上Ditto同上 MMM xxxxxCleaning 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(jié)果Ditto同上Ditto同上See validation protocol 見清潔驗證方案 QA * Sample No. see the four sampling points on Table9. 取樣部位： 共4個取樣點見表9.Attachment附件8: Risk Analysis Table for active ingredient風(fēng)險分析表:FormatA+B Equipment Name 設(shè)備名稱: METAL DETECTOR Date日期: 金屬探測儀1234*Critical關(guān)鍵Risk for Process Step風(fēng)險 Eval.of risk風(fēng)險評估Followupof risk是否確認(rèn)為有風(fēng)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(fù)責(zé)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加料斗出料斗廢片出口Inner surface內(nèi)表面Inner surface內(nèi)表面Inner surface內(nèi)表面XXXPossibility of contamination with pre