【正文】 fined 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(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)盤沖頭和沖模?？譏nner 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 prot。 微生物限度符合要求。 revalidate the items, which are not applicable before.修改驗(yàn)證計(jì)劃，對(duì)不符合的項(xiàng)目進(jìn)行重驗(yàn)證。 QA，QC and the production department calculate with the results of inspect.QA，QC及生產(chǎn)部對(duì)檢查結(jié)果進(jìn)行討論 millJZF400型整粒、粉碎機(jī)Total are 6 samples:總共6個(gè)取樣點(diǎn):Table 17表17: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積蓋子內(nèi)表面JZF400A25內(nèi)表面JZF400B25容器內(nèi)側(cè)面JZF400C25內(nèi)底部JZF400D25出料口表面JZF400E25表面JZF400F25 DPP250B blister packaging machineDPP250B型多功能自動(dòng)鋁塑包裝機(jī)Total are 4 samples:總共4個(gè)取樣點(diǎn):Table 18表18: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積加料斗側(cè)面DPP250B125底部DPP250B225分料刷表面DPP250B325滾刷表面DPP250B425 METAL DETECTOR金屬探測(cè)儀Total are 4 samples:總共4個(gè)取樣點(diǎn):Table 19表19: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積加料斗上側(cè)面MA25下側(cè)面MB25出料斗內(nèi)表面MC25廢片出口內(nèi)表面MD25 BGD150D highefficiency coating machine包衣機(jī)Total are 8 samples:總共8個(gè)取樣點(diǎn):Table 20表20: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積配料鍋?lái)敳緽GD150DA25側(cè)面BGD150DB25底部BGD150DC25包衣鍋側(cè)面BGD150DD25底部BGD150DE25頂部BGD150DF25接縫處BGD150DG25邊緣BGD150DH25 Ringing sampling淋洗水取樣BGD150D highefficiency coating machine包衣機(jī)Sampling location取樣部位：硅膠管、噴槍Three－dimensional mixer HLD1000B型料斗式混合機(jī)清潔操作規(guī)程Sampling location取樣部位：腔體10. Action taken when outoflimit result found對(duì)不符合接受限度的測(cè)試結(jié)果所采取的措施風(fēng)險(xiǎn)分析見附件1到附件18：風(fēng)險(xiǎn)分析表9. Sampling Plan抽樣計(jì)劃 For active ingredient活性成分 Swab sampling擦拭法The following location will be sampled as risk analysis: 根據(jù)風(fēng)險(xiǎn)分析，在下列抽樣部位取樣： shear mixer/granulator HLSG300高效濕法混合制粒機(jī)Total are 7 samples:總共7個(gè)取樣點(diǎn):Table 3表3:Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積Pan制粒鍋Side側(cè)面HLSG3001200Underside底面HLSG3002200出料口Inner surface內(nèi)表面HLSG3003200腔蓋Rim area under the seal 蓋的邊緣 HLSG3004200內(nèi)表面HLSG3005200切粒切刀槳片HLSG3006全部攪拌切刀下表面HLSG3007200 ZP43Tablet Press ZP43旋轉(zhuǎn)式壓片機(jī)Total are 8 samples:總共8個(gè)取樣點(diǎn):Table 5表5: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積下料斗內(nèi)表面PG1ZP431200飼料靴表面PG1ZP432200孔PG1ZP433200出片器內(nèi)表面PG1ZP434200除粉器內(nèi)表面PG1ZP435200轉(zhuǎn)盤側(cè)面PG1ZP436200底面PG1ZP437200?？變?nèi)表面PG1ZP438200 HLD1000BHLD1000B Hopper type of blender HLD1000料斗式混合機(jī)Total are 3 samples:總共3個(gè)取樣點(diǎn):Table 6表6: Part Name部件名稱Sampling Location取樣位置Sampling No.取樣點(diǎn)Swab Area Ss (cm2)取樣面積加料口內(nèi)表面JSH6001200邊緣JSH6002200出料口內(nèi)表面JSH6003200 JZF400 granulators amp。 100 CFU/mll Acceptance Criteria of assay化學(xué)測(cè)試接受限度 Active Ingredient (see Attachment 26) 活性成分 (見附件26) MC (mg/swab) = (Active) For rinsing samples 對(duì)