歐盟清潔驗(yàn)證方案(帶風(fēng)險(xiǎn)分析)

1、Abcd上海勃林格殷格翰藥業(yè)有限公司 Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd.Cleaning Validation 清 潔 驗(yàn) 證 方 案ProtocolSystem Name / 設(shè)備名：氣 霧 劑 生 產(chǎn) 線MDI Production Line Document No. /文件號(hào)： CV-04-P.01Page / 頁(yè)數(shù): PAGE 9 of 15Attachments / 附件:7Responsible Department/ 負(fù)責(zé)部門：Responsible Person/負(fù)責(zé)人：Start Date/起始日期：

2、Production Dept./生產(chǎn)部Mr. XL. Yin/殷雪林Subjeect/主題Lovasstattin Tabbletts 220mgg Clleanningg Vaaliddatiion Prootoccol鯊魚軟骨片片清潔驗(yàn)驗(yàn)證方案案文件編號(hào)：Tablee off coonteentss目錄1. Reespoonsiibillityy職責(zé)2. Puurpoose 目的3. Frrequuenccy 周期4. Reelevvantt SOOPss 相關(guān)的 SOPPs5. Eqquippmennt 設(shè)備6. Teest Metthodd 測(cè)試方法法7. Acccepptannce

3、 Criiterria 接受限度度8. Riisk Anaalyssis 風(fēng)險(xiǎn)分析析9. Saampllingg Pllan 抽樣計(jì)劃劃10. AActiion takken wheen oout-of-limmit ressultt fooundd對(duì)不符合接接受限度度的測(cè)試試結(jié)果所所采取的的措施12. RRevaaliddatiion 再驗(yàn)證13. CCleaaninng VValiidattionn Exxecuutivve RRecoord清潔驗(yàn)證過過程記錄錄14. CConcclussionn結(jié)論Attacchmeentss附件 Writtten by: 制訂者者：Date: 日期：R

4、evieewedd byy: 復(fù)復(fù)核者：Date: 日期：Approovedd byy: 批批準(zhǔn)者：Date: 日期：Approovedd byy: 批批準(zhǔn)者：Date: 日期：1. Reespoonsiibillityy 職責(zé)QA iss reespoonsiiblee foor pplann thhe ccleaaninng vvaliidattionn. QA負(fù)責(zé)整整個(gè)清潔潔驗(yàn)證的的安排QC iss reespoonsiiblee foor ssampplinng aand anaalyssis.QC 負(fù)責(zé)責(zé)抽樣及及測(cè)試Produuctiion Depparttmennt iis rre

5、spponssiblle ffor perrforrminng ccleaaninng pprodducttionn eqquippmennt.生產(chǎn)部負(fù)負(fù)責(zé)設(shè)備備的清潔潔.2. Puurpoose目目的The ppurpposee off thhis cleeaniing vallidaatioon pprottocool iis tto ddemoonsttratte tthatt thhe ccleaaninng pprocceduure useed tto ccleaan JJHZ-2500B hhighh shhearr miixerr / graanullatoor, thrreed

6、immenssionnal mixxer，CCT-CC-2 Hott Aiir CCircculaatinng DDrieer， JZFF-4000 ggrannulaatorrs & miill Korrschh PHH3000-366 Taableet PPresss，BGDD-1550D higgh-eeffiicieencyy cooatiing macchinne andd DPPP-2250BB bllistter pacckaggingg maachiine cann efffecctivvelyy reemovve rresiiduees oof tthe prooduccts

7、 mannufaactuuredd inn ZSS-6550 VVorttex Osccilllatoor/CComppactt Siievee，JHHZ-2250BB hiigh sheear mixxer / ggrannulaatorr, tthreeeddimeensiionaal mmixeer，CCT-CC-2 Hott Aiir CCircculaatinng DDrieer， JZFF-4000 ggrannulaatorrs & miill Korrschh PHH3000-366 Taableet PPresss，BGDD-1550D higgh-eeffiicieency

8、y cooatiing macchinne andd DPPP-2250BB bllistter pacckaggingg maachiine to a ppreddeteermiinedd leevell thhat doees nnot raiise anyy saafetty cconccernns.清洗驗(yàn)證方方案的目目的是證證明JHHZ-2250BB高效濕濕法制粒粒機(jī)、 HLDD-10000BB型料斗斗式混合合機(jī)清潔潔操作規(guī)規(guī)程、CT-T-III型熱熱風(fēng)循環(huán)環(huán)烘箱、JJZF-4000型整粒粒、粉碎碎機(jī)、Korrschh PHH-3000-336旋轉(zhuǎn)轉(zhuǎn)式壓片片機(jī)、BBGD-1500D型高

9、高效包衣衣機(jī)和DPPP-2550B型型多功能能自動(dòng)鋁鋁塑包裝裝所使用用的清洗洗程序能能夠有效效地除去去產(chǎn)品殘殘留，達(dá)達(dá)到預(yù)先先確定的的限度，從從而達(dá)到到對(duì)下批批產(chǎn)品無無影響。 3. Frrequuenccy周期期The ccleaaninng vvaliidattionn sttudyy iss peerfoormeed aafteer tthreee cconssecuutivve mmajoor ccleaaninngs of ZS-6500 Voorteex OOsciillaatorr/Coompaact Sieeve，JJHZ-2500B hhighh shhearr miixerr

10、 / graanullatoor, thrreedimmenssionnal mixxer，CCT-CC-2 Hott Aiir CCircculaatinng DDrieer， JZFF-4000 ggrannulaatorrs & miill Korrschh PHH3000-366 Taableet PPresss，BGDD-1550D higgh-eeffiicieencyy cooatiing macchinne andd DPPP-2250BB bllistter pacckaggingg maachiine aftter thee maanuffactturee off Loov

11、asstattin Tabbletts.連續(xù)三批生生產(chǎn)后，進(jìn)進(jìn)行清洗洗驗(yàn)證研研究。4. Reelevvantt SOOPss相關(guān)的的 SOOPssSOP-PPD-3304-00Cleanningg prroceedurre fforHHLSGG-3000Hiigh Speeed Mixxer/GraanullatoorHLSG-3000型高效效濕法混混合制粒粒機(jī)清潔潔操作規(guī)程程SOP-PPD-3304-00Cleanningg prroceedurre fforLLF1220E-B airrpillloww-drry GraanullatoorLF1200E-BB型沸騰干干燥制粒粒機(jī)清潔潔操作

12、規(guī)規(guī)程SOP-PPD-3310-00Cleanningg prroceedurre ffor ZP443 Higgh SSpeeed rrotaary tabblett prresss高效ZP443旋轉(zhuǎn)轉(zhuǎn)式壓片片機(jī)清潔潔操作規(guī)程程SOP-PPD-3307-000Cleanningg prroceedurre ffor HLDD-10000BB Hooppeer ttypee off bllendderHLD-110000B型料斗式式混合機(jī)清潔潔操作規(guī)程程SOP-PPD-3306-00Cleanningg prroceedurre ffor YK-1600 graanullatoors YK-1

13、660整粒粒機(jī)清潔潔操作規(guī)程程SOP-PPD-3311-00Cleanningg prroceedurre ffor BG-3000E hhighh-effficcienncy coaatinng mmachhineeBG-3000E型型高效包包衣機(jī)清清潔操作作規(guī)程SOP-PPD-3313-00Cleanningg prroceedurre fforDDPH-1300、 DDPP-2500B bblissterr paackaaginng mmachhinee DPH-1130、DPP-250型鋁塑袍罩包裝機(jī)清潔操作規(guī)程ESS-VVD0007Validdatiion guiidellinee

14、clleanningg驗(yàn)證指南清潔驗(yàn)驗(yàn)證ESS-VVD0111Surfaace sammpliing forr clleanningg vaaliddatiion清洗驗(yàn)證設(shè)設(shè)備表面面取樣ESS-VVD0114Selecctioon oof tthe worrst casse iin ccleaaninng vvaliidattionn清潔驗(yàn)證中中最壞情情況的選選擇SOP-QQC-110755檢驗(yàn)操作規(guī)規(guī)程ESS-GGM0666Microobe Tesst 微生物限度度檢測(cè)法法Equippmennts設(shè)設(shè)備No.序號(hào)Equippmennt NNo.設(shè)備編號(hào)Equippmennt NNamee設(shè)備

15、名稱Produuct Conntacct SSurffacee Arrea與產(chǎn)品接觸觸面積(m2)1HLSG-3000 hiigh speeed mmixeer / grranuulattorHLSG-3000高效濕濕法混合合制粒機(jī)機(jī)2.81LF1200E-BB airrpillloww-drry GraanullatoorLF1200E-BB沸騰干干燥制粒粒機(jī)器5.903ZP43TTabllet PreessZP43旋旋轉(zhuǎn)式壓壓片機(jī)64METALL DEETECCTORR金屬探測(cè)儀儀0.35HLD-110000BHLLD-110000B HHoppper typpe oof bblennde

16、rrHLD-110000B型料斗式式混合機(jī)機(jī)5.256YK-1660grranuulattorss YK-1660型整整粒機(jī)0.377DPH-1130DPPP-2550bllistter pacckaggingg maachiineDPH-1130、DDPP-2500型多功功能自動(dòng)動(dòng)鋁塑包包裝機(jī)1.08BG-3000Ehhighh-effficcienncy coaatinng mmachhineeBG-3000E型型高效包包衣機(jī)8.43Totall Prroduuct Conntacct SSurffacee Arrea (m2)與產(chǎn)品接觸觸面積總總和(mm2)99.6225.1 LList

17、t off Eqquippmennt設(shè)備備清單The llistt off Eqquippmennt uusedd inn thhe mmanuufaccturre oof LLovaastaatinn Taableets:有關(guān)鯊魚軟軟骨片生生產(chǎn)線的的所有機(jī)機(jī)器列出出如下：1HLSSG-3300 higgh sspeeed mmixeer / grranuulattor HLSSG-3300高高效濕法法混合制粒粒機(jī) 2. LF1220E-B airrpillloww-drry GGrannulaatorr LF1120EE-B沸沸騰干燥燥制粒機(jī)機(jī)器 3. ZP443Taableet PPres

18、ss ZZP433 Taableet PPresss ZZP433旋轉(zhuǎn)式式壓片機(jī)機(jī) 4. METTAL DETTECTTOR 金屬探探測(cè)儀 5. HLDD-10000BBHLDD-10000BB Hooppeer ttypee off bllendder HLDD-10000BB 型料斗式式混合機(jī)機(jī) 66. YYK-1160ggrannulaatorrs YK-1600 型整整粒機(jī)7. DPPH-1130DPPP-2550bllistter pacckaggingg maachiine DPHH-1330、DDPP-2500型多功功能自動(dòng)動(dòng)鋁塑包包裝機(jī)8. BGG-3000Ehhighh-ef

19、fficcienncy coaatinng mmachhinee BG-3000E型高高效包衣衣機(jī)Tablee 1表表1:5.2 Vaaliddatiion Scoope驗(yàn)驗(yàn)證范圍圍 HLSG-3000 hiigh sheear mixxer / ggrannulaatorr HLSSG-3300高高效濕法法制粒機(jī)機(jī)LF1200E-BB airrpillloww-drry Grranuulattor LF1120EE-B沸沸騰干燥燥制粒機(jī)器ZP43TTabllet Preess ZP443旋轉(zhuǎn)轉(zhuǎn)式壓片片機(jī)METALL DEETECCTORR 金金屬探測(cè)測(cè)儀HLD-110000B grannul

20、ee mixxer HLD-10000BB型料斗式式混合機(jī)機(jī)YK-1660 graanullatoors YYK-1160型型整粒機(jī)機(jī)DPH-1130、DDPP-2500 bllistter pacckaggingg maachiine DPPH-1130、DDPP-2500型多功功能 自動(dòng)鋁鋁塑包裝裝機(jī)BG-3000Ehhighh-effficcienncy coaatinng mmachhinee BG-3000E型高高效包衣衣機(jī)Test Metthodd測(cè)試方方法The ccleaaninng vvaliidattionn sttudiies aree baasedd onn thhe

21、sswabbbinng ttechhniqque andd riinsiing sammpliing. TThe sellectted swaabs shoouldd bee chharaacteerizzed forr thheirr suuitaabillityy annd aa reecovveryy teest shoouldd bee peerfoormeed pprioor tto tthe vallidaatioon sstuddiess. Thee vaaliddatiion stuudiees iinclludee swwabbbingg off thhe mmainn su

22、urfaace areea aas wwelll ass thhe hhardd-too-clleann loocattionns. Swwabbbingg annd rringgingg iss caarriied outt foor tthe acttivee inngreedieent.清潔驗(yàn)證研研究用擦擦拭取樣樣法和最終淋淋洗水取取樣。驗(yàn)驗(yàn)證研究究之前，選選擇的棉棉簽的特特性應(yīng)適適合并進(jìn)進(jìn)行回收收率研究究。驗(yàn)證證研究包包括主要要表面積積和難清清潔部位位的擦拭拭。對(duì)活活性成分分擦拭取取樣和淋淋洗水取取樣。Sampllingg Meethood抽樣樣方法Swab Sammpliing擦擦拭

23、法Ringiing sammpliing最最終淋洗洗水取樣樣法Accepptannce Criiterria 接受限度Visuaal IInsppecttionn目測(cè)檢查Accepptannce Criiterria接受限度Theree iss noo viisibble ressiduue iin eequiipmeent surrfacce aafteer ccleaaninng.設(shè)備在清潔潔后，無無可見的的物質(zhì)殘殘留在設(shè)設(shè)備表面面Accepptannce Criiterria of miccrobbe微生物測(cè)試試接受限限度For sswabb saamplles 對(duì)擦拭樣品品：Micro

24、obess微生物物含量: 2 CFUU/cmm2 ，即 500 CFFU / 255 cmm2For rrinssingg saamplles / 對(duì)對(duì)沖淋樣樣品：Microobess微生物物含量: 1000 CFUU/mllAccepptannce Criiterria of asssay化學(xué)測(cè)試接接受限度度 AActiive Inggreddiennt (seee Atttacchmeent 26)活活性成分分 (見附附件266)MMC (mg/swaab) = _0.008433_ (AActiive) Foor rrinssingg saamplles 對(duì)沖淋樣樣品：MC (mmg/L

25、L) = _00.0884_ (AActiive)Test freequeencyy檢測(cè)次數(shù)The ccleaaninng vvaliidattionn sttudiies aree coonduucteed aafteer tthreee cconssecuutivve mmajoor ccleaaninngs of Nouurkrrin Tabbletts.三批鯊魚軟軟骨片生生產(chǎn)結(jié)束束后進(jìn)行行清洗驗(yàn)驗(yàn)證。Risk Anaalyssis風(fēng)風(fēng)險(xiǎn)分析析 The rresiiduees oof tthe prooduccts aree noot ddisttribbuteed uunifformm

26、ityy, sso tthe rissk aanallysiis sshouuld be doone befforee clleanningg vaaliddatiion sammpliing. Thhe CCritticaal llocaatioon wwilll bee deeterrminned at rissk aanallysiis. Rissk aanallysees aare summmarrizeed iin AAttaachmmentt 1aand Atttachhmennt 118.由于上一產(chǎn)產(chǎn)品生產(chǎn)產(chǎn)對(duì)下一一產(chǎn)品的的污染并并不是均均勻分布布在整個(gè)個(gè)設(shè)備的的接觸面面上，因因

27、此清潔潔驗(yàn)證的的活性成成分抽樣樣計(jì)劃的的確定必必須先進(jìn)進(jìn)行風(fēng)險(xiǎn)險(xiǎn)分析，且且在風(fēng)險(xiǎn)險(xiǎn)分析中中確定清清潔驗(yàn)證證的關(guān)鍵鍵部位。風(fēng)風(fēng)險(xiǎn)分析析見附件件1到附件件18：風(fēng)風(fēng)險(xiǎn)分析析表Sampllingg Pllan抽樣計(jì)劃 For acttivee ingrrediientt活性成成分9.1 SSwabb saampllingg擦拭法The ffolllowiing loccatiion willl bbe ssamppledd ass riisk anaalyssis: 根據(jù)風(fēng)風(fēng)險(xiǎn)分析析，在下下列抽樣樣部位取取樣：9.1.11HLSSG-3300hhighh shhearr miixerr/grranu

28、ulattor HLSG-3000高效濕濕法混合合制粒機(jī)機(jī)Totall arre 77 saamplles:總共7個(gè)取取樣點(diǎn):Tablee 3表表3:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積Pan制粒鍋Side側(cè)側(cè)面HLSG-3000-1200Underrsidde底面面HLSG-3000-2200出料口Innerr suurfaace內(nèi)內(nèi)表面HLSG-30003200腔蓋Rim aareaa unnderr thhe sseall 蓋的邊緣 HLSG-3000-420

29、0內(nèi)表面HLSG-3000-5200切粒切刀槳片HLSG-3000-6全部攪拌切刀下表面HLSG-3000-72009.1.33 ZPP43TTabllet Preess ZP43旋旋轉(zhuǎn)式壓壓片機(jī)Totall arre 88 saamplles:總共8個(gè)取取樣點(diǎn):Tablee 5表表5:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積下料斗內(nèi)表面PG16、ZZP433-1200飼料靴表面PG16、ZZP433-2200孔PG16、ZZP433-3200出片器內(nèi)表面PG16、ZZ

30、P433-4200除粉器內(nèi)表面PG16、ZZP433-5200轉(zhuǎn)盤側(cè)面PG16、ZZP433-6200底面PG16、ZZP433-7200?？變?nèi)表面PG16、ZZP433-8200HLD-110000BHLLD-110000B HHoppper typpe oof bblennderr HLD-110000料斗式式混合機(jī)機(jī)Totall arre 33 saamplles:總共3個(gè)取取樣點(diǎn):Tablee 6表6:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料口內(nèi)表面JSH-

31、6600-1200邊緣JSH-6600-2200出料口內(nèi)表面JSH-6600-32009.1.66 JZFF-4000 graanullatoors & mmilllJZF-4400型型整粒、粉粉碎機(jī)Totall arre 66 saamplles:總共6個(gè)取取樣點(diǎn):Tablee 8表8:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積蓋子內(nèi)表面JZF-4400-1200內(nèi)表面JZF-4400-2200容器內(nèi)側(cè)面JZF-4400-3200內(nèi)底部JZF-4400-4200出料口表

32、面JZF-4400-5200表面JZF-4400-62009.1.77 DPPP-2550B bliisteer ppackkagiing macchinneDPP-2250BB型多功功能自動(dòng)動(dòng)鋁塑包包裝機(jī)Totall arre 44 saamplles:總共4個(gè)取取樣點(diǎn):Tablee 9表9:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料斗側(cè)面DPP-2250BB-1200底部DPP-2250BB-2200分料刷表面DPP-2250BB-3200滾刷表面DPP-2250

33、BB-42009.1.88 METTAL DETTECTTOR金屬探測(cè)儀儀Totall arre 44 saamplles:總共4個(gè)取取樣點(diǎn):Tablee 100表10:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料斗上側(cè)面M-1200下側(cè)面M-2200出料斗內(nèi)表面M-3200廢片出口內(nèi)表面M-42009.1.99 BGGD-1150DD hiigh-effficiienccy ccoattingg maachiine包衣機(jī)Totall arre 88 saamplles

34、:總共8個(gè)取取樣點(diǎn):Tablee 111表11:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積配料鍋頂部BGD-1150DD-1200側(cè)面BGD-1150DD-2200底部BGD-1150DD-3200包衣鍋側(cè)面BGD-1150DD-4200底部BGD-1150DD-5200頂部BGD-1150DD-6200接縫處BGD-1150DD-7200邊緣BGD-1150DD-82009.2 RRinggingg saampllingg淋洗水水取樣BGD-1150DD hiigh-e

35、ffficiienccy ccoattingg maachiine包包衣機(jī)Sampllingg loocattionn取樣部部位：硅硅膠管、噴噴槍Threeedimmenssionnal mixxer HLDD-10000BB型料斗斗式混合合機(jī)清潔潔操作規(guī)規(guī)程Sampllingg loocattionn取樣部部位：腔腔體For MMicrrobees微生物取樣樣點(diǎn)9.3.11 JHHZ-2250BB hiigh sheear mixxer/graanullatoor JHZ-2250BB高效濕濕法制粒粒機(jī)Totall arre 77 saamplles:總共7個(gè)取取樣點(diǎn):Tablee 122表

36、12:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積Pan制粒鍋Side側(cè)側(cè)面JHZ-2250BB-A25Underrsidde底面面JHZ-2250BB-B25出料口Innerr suurfaace內(nèi)內(nèi)表面JHZ-2250BB-C25腔蓋Rim aareaa unnderr thhe sseall 蓋的邊緣 JHZ-2250BB-D25內(nèi)表面JHZ-2250BB-E25切粒切刀槳片JHZ-2250BB-F25攪拌切刀下表面JHZ-2250BB-G259.3.22 ZSS-6

37、550 VVorttex Osccilllatoor/CComppactt Siievee ZS-6550漩渦渦振蕩篩篩Totall arre 55 saamplles:總共5個(gè)取取樣點(diǎn):Tablee 133表13:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積上蓋內(nèi)表面ZS-6550-AA25篩網(wǎng)上表面ZS-6550-BB25出料口內(nèi)表面ZS-6550-CC25密封圈內(nèi)表面ZS-6550-DD25容器內(nèi)表面ZS-6550-EE259.3.33 Korrschh PHH300

38、0-366 Taableet PPresss KORSCCH PPH-3300-36旋旋轉(zhuǎn)式壓壓片機(jī)Totall arre 88 saamplles:總共8個(gè)取取樣點(diǎn):Tablee 144表14:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積下料斗內(nèi)表面PH-3000-336-AA25飼料靴表面PH-3000-336-BB25孔PH-3000-336-CC25出片器內(nèi)表面PH-3000-336-DD25除粉器內(nèi)表面PH-3000-336-EE25轉(zhuǎn)盤側(cè)面PH-3000-336

39、-FF25底面PH-3000-336-GG25?？變?nèi)表面PH-3000-336-HH259.3.44 Thrreedimmenssionnal mixxerHLD-110000B型料料斗式混混合機(jī)清清潔操作作規(guī)程Totall arre 33 saamplles:總共3個(gè)取取樣點(diǎn):Tablee 155表15:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料口內(nèi)表面JSH-6600-A25邊緣JSH-6600-B25出料口內(nèi)表面JSH-6600-C259.3.55 CT-C-2

40、2 Hott Aiir CCircculaatinng DDrieerCT-C-2型熱熱風(fēng)循環(huán)環(huán)烘箱Totall arre 110 saamplles:總共10個(gè)個(gè)取樣點(diǎn)點(diǎn):Tablee 166表16:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積烘盤表面CT-C-2-AA25內(nèi)側(cè)面CT-C-2-BB25箱體左側(cè)CT-C-2-CC25右側(cè)CT-C-2-DD25頂部CT-C-2-EE25接縫處CT-C-2-FF25臺(tái)車托架CT-C-2-GG25邊緣CT-C-2-HH25箱門內(nèi)表

41、面CT-C-2-II25密封條CT-C-2-JJ259.3.66 JZFF-4000 graanullatoors & mmilllJZF-4400型型整粒、粉粉碎機(jī)Totall arre 66 saamplles:總共6個(gè)取取樣點(diǎn):Tablee 177表17:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積蓋子內(nèi)表面JZF-4400-A25內(nèi)表面JZF-4400-B25容器內(nèi)側(cè)面JZF-4400-C25內(nèi)底部JZF-4400-D25出料口表面JZF-4400-E25表面JZF

42、-4400-F259.3.77 DPPP-2550B bliisteer ppackkagiing macchinneDPP-2250BB型多功功能自動(dòng)動(dòng)鋁塑包包裝機(jī)Totall arre 44 saamplles:總共4個(gè)取取樣點(diǎn):Tablee 188表18:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料斗側(cè)面DPP-2250BB-125底部DPP-2250BB-225分料刷表面DPP-2250BB-325滾刷表面DPP-2250BB-4259.3.88 METTAL

43、DETTECTTOR金屬探測(cè)儀儀Totall arre 44 saamplles:總共4個(gè)取取樣點(diǎn):Tablee 199表19:Part Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積加料斗上側(cè)面M-A25下側(cè)面M-B25出料斗內(nèi)表面M-C25廢片出口內(nèi)表面M-D259.3.99 BGGD-1150DD hiigh-effficiienccy ccoattingg maachiine包衣機(jī)Totall arre 88 saamplles:總共8個(gè)取取樣點(diǎn):Tablee 200表20:P

44、art Namme部件名稱Sampllingg Loocattionn取樣位置Sampllingg Noo.取樣點(diǎn)Swab Areea SSs (cm22)取樣面積配料鍋頂部BGD-1150DD-A25側(cè)面BGD-1150DD-B25底部BGD-1150DD-C25包衣鍋側(cè)面BGD-1150DD-D25底部BGD-1150DD-E25頂部BGD-1150DD-F25接縫處BGD-1150DD-G25邊緣BGD-1150DD-H259.4 RRinggingg saampllingg淋洗水水取樣BGD-1150DD hiigh-effficiienccy ccoattingg maachiine

45、包包衣機(jī)Sampllingg loocattionn取樣部部位：硅硅膠管、噴噴槍Threeedimmenssionnal mixxer HLDD-10000BB型料斗斗式混合合機(jī)清潔潔操作規(guī)規(guī)程Sampllingg loocattionn取樣部部位：腔腔體Actioon ttakeen wwhenn ouut-oof-llimiit rresuult fouund對(duì)不符合接接受限度度的測(cè)試試結(jié)果所所采取的的措施Inspeect thee prroceess of opeerattionn檢查測(cè)試過過程Inspeect thee eqquippmennt oof aassaay檢查查分析所所用的

46、儀儀器 Inspeect thee sttep of opeerattionn檢查實(shí)實(shí)驗(yàn)步驟驟Inspeect thee prroceess of sammpliing檢檢查抽樣樣過程QA，QCC annd tthe prooducctioon ddepaartmmentt caalcuulatte wwithh thhe rresuultss off innspeect.QA，QCC及生產(chǎn)產(chǎn)部對(duì)檢檢查結(jié)果果進(jìn)行討討論Modiffy tthe vallidaatioon pplann; rrevaaliddatee thhe iitemms, whiich aree noot aappllic

47、aablee beeforre.修改驗(yàn)證計(jì)計(jì)劃，對(duì)對(duì)不符合合的項(xiàng)目目進(jìn)行重重驗(yàn)證。Revallidaatioon再驗(yàn)證Revallidaatioon sshouuld be connsiddereed uundeer tthe folllowwingg ciircuumsttancces:在下列情況況發(fā)生時(shí)時(shí)，必須須考慮是是否要進(jìn)進(jìn)行重驗(yàn)驗(yàn)證：Cleanningg meethood cchanngedd/清潔潔程序變變化時(shí)Cleanningg deeterrgennts chaangeed/清清潔劑變變化時(shí)Produuct chaangeed/產(chǎn)產(chǎn)品變化化時(shí)Cleanningg Vaalidd

48、atiion Exeecuttivee Reecorrd清潔驗(yàn)證過過程記錄錄 附件1-118Rissk AAnallysiis TTablle風(fēng)險(xiǎn)險(xiǎn)分析表表附件19Vissuall Innspeectiion andd Saampllingg foor AActiive Inggreddiennt目檢檢和取樣樣附件20Vissuall Innspeectiion andd Saampllingg foor MMicrrobees目檢檢和取樣樣附件21Anaalytticaal RResuultss foor AActiive Inggreddiennt分析析結(jié)果附件22Anaalytticaa

49、l RResuultss foor MMicrrobees分析析結(jié)果附件23 Sammpliing Reccoveery Tesst取樣樣回收率率試驗(yàn)附件24 Swaab CChaccterrizaatioon ffor Cleeaniing Vallidaatioon清洗驗(yàn)證棉棉簽特性性研究附件25 Swaab SSampplinng ffor Cleeaniing Vallidaatioon清洗洗驗(yàn)證棉棉簽取樣樣附件26 Callcullatiion forr Acccepttancce CCritteriia接受受限度的的計(jì)算 14. COONCLLUSIION結(jié)論The ressult

50、ts oobtaaineed sshouuld nott exxceeed tthe callcullateed cconttamiinattionn liimitt. Thee clleanningg prroceedurre ffor alll piiecees oof pprodducttionn eqquippmennt eeffeectiivelly rremoovess reesidduess off Loovasstattin Tabbletts mmanuufaccturred in thiis eequiipmeent andd iss thhereeforre ddeemm

51、ed vallidaatedd. Microobess liimitt coomplly wwithh thhe rrequuireemennt.測(cè)試結(jié)果果不得大大于計(jì)算算出的檢檢測(cè)限.設(shè)備的的清潔程程序可以以有效清清除產(chǎn)品品殘留，認(rèn)認(rèn)為驗(yàn)證證有效。 微微生物限限度符合合要求。Attacchmeent附附件1: Riisk Anaalyssis Tabble forr acctivve iingrrediientt風(fēng)險(xiǎn)分分析表:FormatA+B Equuipmmentt Naame 設(shè)備名名稱: JHZZ-2550B Higgh SSheaar MMixeer / Grranuulattor

52、 Daate日日期: FormatA+BJHZ-2250BB高效濕濕法制粒粒機(jī)12341.11.2*2.1Critiicall關(guān)鍵3.1Risk forr Prroceess Steep風(fēng)險(xiǎn) 3.2Eval.of riisk風(fēng)險(xiǎn)評(píng)估3.3Folloow-uupof riisk是否確認(rèn)為為有風(fēng)險(xiǎn)險(xiǎn)4.1Possiiblee caausee可能的原因因4.2Validdatiion meaasurr驗(yàn)證措施4.3Validdatiion plaan驗(yàn)證計(jì)劃4.4Date日期4.5Respoonsiiblee peersoon負(fù)責(zé)人No.序號(hào)CompoonenntName部件名稱Sam. No.取樣

53、部位Contaact Areea藥品接觸表表面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Innerr suurfaace內(nèi)表面內(nèi)表面內(nèi)表面表面表面XXXXPossiibillityy off coontaaminnatiion witth pprevviouus pprodductt與前批產(chǎn)品品交叉污污染的可可能性Dittoo同上Dittoo同上 Dittoo同上MMMHHXxxxXCleanningg prroceedurre oof SSOP is nott effficciennt清潔方法不不足夠有有效Dittoo同上Dittoo同上Dittoo同上 Chec

54、kk clleanningg reesullt aat ddefiinedd loocattionn在規(guī)定部位位檢查清清潔結(jié)果果Dittoo同上Dittoo同上Dittoo同上 See vvaliidattionn prrotoocoll 見清潔驗(yàn)證證方案 1.2* Saamplle NNo. seee thhe sseveen ssampplinng ppoinnts on Tabble33. 取取樣部位位： 共7個(gè)取樣樣點(diǎn) 見表3.Attacchmeent附附件2 : RRiskk Annalyysiss Taablee foor aactiive ingrrediientt風(fēng)險(xiǎn)分分析表:

55、FormatA+B Eqquippmennt NNamee設(shè)備名名稱: ZSS-6550 VVorttex Osccilllatoor/CComppactt Siievee DDatee日期: FormatA+BZS-6550漩渦渦振蕩篩篩12341.11.22.1Critiicall關(guān)鍵3.1Risk forr Prroceess Steep風(fēng)險(xiǎn) 3.2Eval.of riisk風(fēng)險(xiǎn)評(píng)估3.3Folloow-uupof riisk是否確認(rèn)為為有風(fēng)險(xiǎn)險(xiǎn)4.1Possiiblee caausee可能的原因因4.2Validdatiion meaasurre驗(yàn)證措施4.3Validdatiion

56、plaan驗(yàn)證計(jì)劃4.4Date日期4.5Respoonsiiblee peersoon負(fù)責(zé)人No序號(hào) CoompoonenntName部件名稱*Sam.No.取樣部位ContaactArea藥品接觸表表面 Yess 是No否Yes是No否12345上蓋篩網(wǎng)出料口密封圈容器Innerr suurfaace內(nèi)表面Surfaace表面Surfaace內(nèi)表面內(nèi)表面內(nèi)表面xxxxxPossiibillityy off coontaaminnatiion witth pprevviouus pprodductt與前批產(chǎn)品品交叉污污染的可可能性Dittoo同上Dittoo同上Dittoo同上Dittoo同

57、上LHH MMxxxxXCleanningg prroceedurre oof SSOP is nott effficciennt清潔方法不不足夠有有效 Dittto同上Dittoo同上Dittoo同上Dittoo同上Checkk clleanningg reesullt aat ddefiinedd loocattionn在規(guī)定部位位檢查清清潔結(jié)果果Dittoo同上Dittoo同上Dittoo同上Dittoo同上See vvaliidattionn prrotoocoll 見清清潔驗(yàn)證證方案1.2 * Sammplee Noo. ssee fivve ssampplinng ppoinnts

58、 on Tabble 4. 取樣部部位：共共5個(gè)取樣樣點(diǎn)見表表4.Attacchmeent附附件3: Riisk Anaalyssis Tabble forr acctivve iingrrediientt風(fēng)險(xiǎn)分分析表:FormatA+B Equuipmmentt Naame 設(shè)備名名稱: Korrschh PHH3000-366 Taableet PPresss Datte日期期: FormatA+BKORSCCH PPH-3300-36旋旋轉(zhuǎn)式壓壓片機(jī)12341.11.2*2.1Critiicall關(guān)鍵3.1Risk forr Prroceess Steep風(fēng)險(xiǎn) 3.2Eval.of ri

59、isk風(fēng)險(xiǎn)評(píng)估3.3Folloow-uupof riisk是否確認(rèn)為為有風(fēng)險(xiǎn)險(xiǎn)4.1Possiiblee caausee可能的原因因4.2Validdatiion meaasurr驗(yàn)證措施4.3Validdatiion plaan驗(yàn)證計(jì)劃4.4Date日期4.5Respoonsiiblee peersoon負(fù)責(zé)人No.序號(hào)CompoonenntName部件名稱Sam. No.取樣部位Contaact Areea藥品接觸表表面Yes是No否Yes是No否12345678Hoppeer 下料斗飼料靴出片器除粉器壓片室隔板板轉(zhuǎn)盤沖頭和沖模模?？譏nnerr suurfaace內(nèi)表面表面及孔表面內(nèi)表面

60、表面表面內(nèi)表面內(nèi)表面XXXXXXXXPossiibillityy off coontaaminnatiion witth pprevviouus pprodductt與前批產(chǎn)品品交叉污污染的可可能性Dittoo同上Dittoo同上 Dittoo同上MHM MLMLHxxxxxxxxCleanningg prroceedurre oof SSOP is nott effficciennt清潔方法不不足夠有有效Dittoo同上Dittoo同上Dittoo同上 Dittto同上 Checkk clleanningg reesullt aat ddefiinedd loocattionn在規(guī)定部位位檢