【正文】 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(jiàn)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(jiàn)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(jiàn)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(jiàn)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 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(jiàn)清潔驗(yàn)證方案 * Sample No. see the seven sampling points on Table12. 取樣部位： 共7個(gè)取樣點(diǎn) 見(jiàn)表12.Attachment附件11 : Risk Analysis Table For Microbes風(fēng)險(xiǎn)分析表:FormatA+B Equipment Name設(shè)備名稱: ZS650 Vortex Oscillator/Compact Sieve Date日期: ZS650漩渦振蕩篩1234Critical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 measure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ContactArea藥品接觸表面 Yes 是No否Yes是No否12345上蓋篩網(wǎng)出料口密封圈容器Inner surface內(nèi)表面Surface表面Surface內(nèi)表面內(nèi)表面內(nèi)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Ditto同上LHH MMxxxxXCleaning 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(jiàn)清潔驗(yàn)證方案 * Sample No. see five sampling points on Table 13. 取樣部位：共5個(gè)取樣點(diǎn)見(jiàn)表13.Attachment附件12: Risk Analysis Table For Microbes風(fēng)險(xiǎn)分析表:FormatA+B Equipment Name 設(shè)備名稱: Korsch PH30036 Tablet Press Date日期: KORSCH PH30036旋轉(zhuǎn)式壓片機(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12345678Hopper 下料斗飼料靴出片器除粉器壓片室隔板轉(zhuǎn)盤(pán)沖頭和沖模模孔Inner surface內(nèi)表面表面及孔表面內(nèi)表面表面表面內(nèi)表面內(nèi)表面XXXXXXXXPossibility 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 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(jié)果Ditto同上Ditto同上Ditto同上 Ditto同上See validation pro