【正文】 mill Date日期: JZF400型整粒、粉碎機(jī)1234*Critical關(guān)鍵Risk for Process Step風(fēng)險(xiǎn) Eval.of risk風(fēng)險(xiǎn)評(píng)估Followupof risk是否確認(rèn)為有風(fēng)險(xiǎn)Possible cause可能的原因Validation measur驗(yàn)證措施Validation plan驗(yàn)證計(jì)劃Date日期Responsible person負(fù)責(zé)人No.序號(hào)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(yàn)證方案 QA * Sample No. see the six sampling points on Table 8. 取樣部位： 共6個(gè)取樣點(diǎn)見表8.Attachment附件7: Risk Analysis Table for active ingredient風(fēng)險(xiǎn)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(dòng)鋁塑包裝機(jī)1234*Critical關(guān)鍵Risk for Process Step風(fēng)險(xiǎn) Eval.of risk風(fēng)險(xiǎn)評(píng)估Followupof risk是否確認(rèn)為有風(fēng)險(xiǎn)Possible cause可能的原因Validation measur驗(yàn)證措施Validation plan驗(yàn)證計(jì)劃Date日期Responsible person負(fù)責(zé)人No.序號(hào)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(yàn)證方案 QA * Sample No. see the four sampling points on Table9. 取樣部位： 共4個(gè)取樣點(diǎn)見表9.Attachment附件8: Risk Analysis Table for active ingredient風(fēng)險(xiǎn)分析表:FormatA+B Equipment Name 設(shè)備名稱: METAL DETECTOR Date日期: 金屬探測(cè)儀1234*Critical關(guān)鍵Risk for Process Step風(fēng)險(xiǎn) Eval.of risk風(fēng)險(xiǎn)評(píng)估Followupof risk是否確認(rèn)為有風(fēng)險(xiǎn)Possible cause可能的原因Validation measur驗(yàn)證措施Validation plan驗(yàn)證計(jì)劃Date日期Responsible person負(fù)責(zé)人No.序號(hào)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 previous product與前批產(chǎn)品交叉污染的可能性Ditto同上Ditto同上 MMM 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(yàn)證方案 QA * Sample No. see the four sampling points on Table10. 取樣部位： 共4個(gè)取樣點(diǎn)見表10.Attachment附件9: Risk Analysis Table for active ingredient風(fēng)險(xiǎn)分析表:FormatA+B Equipment Name 設(shè)備名稱: BGD150D highefficiency coating machine Date日期: 包衣機(jī)1234*Critical關(guān)鍵Risk for Process Step風(fēng)險(xiǎn) Eval.of risk風(fēng)險(xiǎn)評(píng)估Followupof risk是否確認(rèn)為有風(fēng)險(xiǎn)Possible cause可能的原因Validation measur驗(yàn)證措施Validation plan驗(yàn)證計(jì)劃Date日期Responsible person負(fù)責(zé)人No.序號(hào)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配料鍋包衣鍋硅膠管噴槍Inner surface內(nèi)表面Surface and hole表面及孔Surface 表面Surface表面Surface 表面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(yàn)證方案 QA * Sample No. see the eight sampling points on Table11. 取樣部位： 共8個(gè)取樣點(diǎn)見表11.Attachment附件10: Risk Analysis Table For Microbes風(fēng)險(xiǎn)分析表:FormatA+B Equipment Name 設(shè)備名稱: JHZ250B High Shear Mixer / Granulator Date日期: JHZ250B高效濕法制粒機(jī)1234*Critical關(guān)鍵Risk for Process Step風(fēng)險(xiǎn) Eval.of risk風(fēng)險(xiǎn)評(píng)估Followupof risk是否確認(rèn)為有風(fēng)險(xiǎn)Possible cause可能的原因Validation measur驗(yàn)證措施Validation plan驗(yàn)證計(jì)劃Date日期Responsible person負(fù)責(zé)人No.序號(hào)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制粒鍋出料口腔蓋切粒切刀攪拌切刀Inner surface內(nèi)表面內(nèi)表面內(nèi)表面表面表面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MMMHHXxxxXCleaning 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 de