1、Subject/ 主題Lovastat in Tablets 20mg Clea ning Validati on Protocol鯊魚軟骨片清潔驗證方案文件編號：Table of contents目錄1. Resp on sibility 職責(zé)2. Purpose目的3. Freque ncy 周期4. Releva nt SOP' s相關(guān)的SOP s5. Equipme nt設(shè)備6. Test Method測試方法7. Accepta nee Criteria 接受限度8. Risk An alysis風(fēng)險分析9. Sampli ng Pla n抽樣計劃10. Action tak

2、e n whe n out-of-limit result found 對不符合接受限度的測試結(jié)果所采取的措施12. Revalidation再驗證13. Clea ning Validati on Executive Record 清潔驗證過程記錄14. Con clusi on結(jié)論Attachme nts 附件Written by:制訂者：Date:日期：Reviewed by:復(fù)核者：Date:日期：Approved by:批準(zhǔn)者：Date:日期：Approved by:批準(zhǔn)者：Date:日期：1. Respo nsibility職責(zé)QA is resp on sible for pla

3、 n the clea ning validati on.QA負(fù)責(zé)整個清潔驗證的安排QC is resp on sible for sampli ng and an alysis.QC負(fù)責(zé)抽樣及測試Product ion Departme nt is resp on sible for perform ing clea ning product ion equipme nt.生產(chǎn)部負(fù)責(zé)設(shè)備的清潔.2. Purpose 目的The purpose of this clea ning validatio n protocol is to dem on strate that the clea ni

4、ng procedure used to clean JHZ-250B high shear mixer / granulator, three dimensional mixer , CT-C-2 Hot Air Circulating Drier, JZF-400 granulators & mill Korsch PH300-36 TabletPress , BGD-150D high-efficie ncy coati ng mach ine andDPP-250B blister packag ing machi necan effectively remove residu

5、es of the products manu factured in ZS-650 Vortex Oscillator/Compact Sieve , JHZ-250B high shear mixer / granulator, three dimensionalmixer , CT-C-2 Hot Air Circulating Drier, JZF-400 granulators & mill Korsch PH300-36Tablet Press , BGD-150D high-efficie ncy coati ng machi ne andDPP-250B blister

6、 packagi ngmach ine to a predeterm ined level that does not raise any safety concerns.清洗驗證方案的目的是證明JHZ-250B高效濕法制粒機(jī)、HLD-1000B型料斗式混合機(jī)清潔操作規(guī)程、CT-T-II型熱風(fēng)循環(huán)烘箱、JZF-400型整粒、粉碎機(jī)、Korsch PH-300-36旋轉(zhuǎn)式壓片機(jī)、 BGD-150D型高效包衣機(jī)和 DPP-250B型多功能自動鋁塑包裝所使用的清洗程序能夠有效地除去產(chǎn) 品殘留，達(dá)到預(yù)先確定的限度，從而達(dá)到對下批產(chǎn)品無影響。3. Frequency 周期The clea ning va

7、lidati on study is performed after three con secutive major clea nings ofZS-650 Vortex Oscillator/Compact Sieve , JHZ-250B high shear mixer / granulator, threedimensional mixer , CT-C-2 Hot Air CirculatingDrier , JZF-400 granulators & mill KorschPH300-36 Tablet Press , BGD-150D high-efficie ncy

8、coati ng machi ne andDPP-250B blisterpackagi ng mach ine after the manufacture of Lovastati n Tablets.連續(xù)三批生產(chǎn)后，進(jìn)行清洗驗證研究。4. Releva nt SOP ' s 相關(guān)的 SOP sSOP-PD-304-00Clea ning procedure forHLSG-300High Speed Mixer/Gra nu latorHLSG-300型高效濕法混合制粒機(jī)清潔操作規(guī)程SOP-PD-304-00Clea ning procedure forLF120E-B airpi

9、llow-dry Gran ulatorLF120E-B型沸騰干燥制粒機(jī)清潔操作規(guī)程SOP-PD-310-00Clea ning procedure for ZP43 High Speed rotary tablet press高效ZP43旋轉(zhuǎn)式壓片機(jī)清潔操作規(guī)程SOP-PD-307-00Clea ning procedure forHLD-1000B Hopper type of ble nderHLD-1000B型料斗式混合機(jī)清潔操作規(guī)程SOP-PD-306-00Clea ning procedure for YK-160gra nu latorsYK-160整粒機(jī)清潔操作規(guī)程SOP-PD

10、-311-00Clea ning procedure for BG-300E high-efficie ncy coat ing mach ineBG-300E型高效包衣機(jī)清潔操作規(guī)程SOP-PD-313-00Clea ning procedure forDPH-130、DPP-250B blister packag ingmach ineDPH-130 DPP-250型鋁塑袍罩包裝機(jī)清潔操作規(guī)程ESS-VD007Validation guideline- cleaning驗證指南-清潔驗證ESS-VD011Surface sampli ng for clea ning validati on

11、清洗驗證設(shè)備表面取樣ESS-VD014Select ion of the worst case in clea ning validatio n清潔驗證中最壞情況的選擇SOP-QC-1075檢驗操作規(guī)程ESS-GM066Microbe Test微生物限度檢測法5. Equipments 設(shè)備No.序 號Equipment No.設(shè)備編號Equipme nt Name設(shè)備名稱Product Con tact SurfaceArea與產(chǎn)品接觸面積（m ）1HLSG-300 high speed mixer / granulatorHLSG-300高效濕法混合制粒機(jī)2.81LF120E-B airp

12、illow-dry Gra nulatorLF120E-B沸騰干燥制粒機(jī)器5.903ZP43Tablet PressZP43旋轉(zhuǎn)式壓片機(jī)64METAL DETECTOR金屬探測儀0.35HLD-1000BHLD-1000B Hopper type of blenderHLD-1000B型料斗式混合機(jī)5.256YK-160gra nulatorsYK-160型整粒機(jī)0.377DPH-130DPP-250blisterpackag ingmachi neDPH-130 DPP-250型多功能自動鋁塑包裝機(jī)1.08BG-300Ehigh-efficie ncy coat ing machi neBG

13、-300E型高效包衣機(jī)8.432Total Product Con tact Surface Area （m）與產(chǎn)品接觸面積總和（m）99.625.1 List of Equipme nt設(shè)備清單The list of Equipme nt used in the manufacture of Lovastati n Tablets:有關(guān)鯊魚軟骨片生產(chǎn)線的所有機(jī)器列出如下：1. HLSG-300 high speed mixer / granulator HLSG-300高效濕法混合制粒機(jī)2. LF120E-B airpillow-dry Gran ulatorLF120E-B 沸騰干燥制粒機(jī)

14、器3. ZP43Tablet Press ZP43 Tablet PressZP43 旋轉(zhuǎn)式壓片機(jī)4.METAL DETECTORS 屬探測儀5. HLD-1000BHLD-1000B Hopper type of ble nder HLD-1000B型料斗式混合機(jī)6. YK-160gra nulators YK-160型整粒機(jī)7. DPH-130DPP-250blister packaging machinedph-130 dpp-250型多功能自動8. BG-300Ehigh-efficiency coating machineBG-300E型高效包衣機(jī)Table 1 表 1:5.2 Va

15、lidation Scope 驗證圍HLSG-300 high shear mixer / granulatorHLSG-300 高效濕法制粒機(jī)LF120E-B airpillow-dry Granulator機(jī)器ZP43Tablet Press ZP43METAL DETECTORHLD-1000B granule mixer HLD-1000BYK-160 granulators YK-160LF120E-B沸騰干燥制粒旋轉(zhuǎn)式壓片機(jī)金屬探測儀型料斗式混合機(jī)型整粒機(jī)DPH-130、DPP-250 blister packaging machine 臺匕能BG-300Ehigh-efficie

16、ncy coating machine6. Test Method 測試方法DPH-130、DPP-250 型多功自動鋁塑包裝機(jī)BG-300E型高效包衣機(jī)The cleaning validation studies are based on the swabbing technique and rinsing sampling. The selected swabs should be characterized for their suitability and a recovery test should be performed prior to the validation stud

17、ies. The validation studies include swabbing of the main surface area as well as the hard-to-clean locations. Swabbing and ringing is carried out for the active ingredient. 清潔驗證研究用擦拭取樣法和最終淋洗水取樣。 驗證研究之前， 選擇的棉簽的特性應(yīng)適合并進(jìn) 行回收率研究。 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。Sampling Method 抽樣方法Swab Sampling 擦拭

18、法Ringing sampling 最終淋洗水取樣法7. Acceptanee Criteria接受限度Visual In spect ion目測檢查Accepta nee Criteria接受限度There is no visible residue in equipme nt surface after clea ning.設(shè)備在清潔后，無可見的物質(zhì)殘留在設(shè)備表面Accepta nee Criteria of microbe微生物測試接受限度- For swab samples 對擦拭樣品：Microbes 微生物含量：2 CFU/cm 2，即 50 CFU / 25 cm 2- For

19、rinsing samples /對沖淋樣品：Microbes 微生物含量：100 CFU/mlAccepta nee Criteria of assay化學(xué)測試接受限度Active In gredie nt (see Attachme nt 26)活性成分(見附件26)MC(mg/swab)=0.0843(Active)For rinsing samples對沖淋樣品：MC(mg/L)=0.084(Active)Test freque ncy檢測次數(shù)The clea ning validati on studies are con ducted after three con secutiv

20、e major clea nings of Nourkri n Tablets.三批鯊魚軟骨片生產(chǎn)結(jié)束后進(jìn)行清洗驗證。8. Risk Analysis風(fēng)險分析The residues of the products are not distributed uniformity, so the risk analysisshouldbe done before cleaning validation sampling. The Criticallocationwill be determinedat risk analysis. Risk analyses are summarized in A

21、ttachment land Attachment 18.由于上一產(chǎn)品生產(chǎn)對下一產(chǎn)品的污染并不是均勻分布在整個設(shè)備的接觸面上，因此清潔驗證 的活性成分抽樣計劃的確定必須先進(jìn)行風(fēng)險分析，且在風(fēng)險分析中確定清潔驗證的關(guān)鍵部 位。風(fēng)險分析見附件 1到附件18:風(fēng)險分析表9. Sampling Plan抽樣計劃For active in gredie nt活性成分9.1 Swab sampli ng擦拭法The following location will be sampled as risk analysis: 根據(jù)風(fēng)險分析，在下列抽樣部位取樣：9.1.1 HLSG-300high shear m

22、ixer/gra nulator HLSG-300高效濕法混合制粒機(jī)Total are 7 samples:總共7個取樣點(diǎn)：Table 3 表 3:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積Pan制粒鍋Side側(cè)面HLSG-300-1200Underside 底面HLSG-300-2200出料口Inner surface 表面HLSG-3003200腔蓋Rim area un der the seal蓋的邊緣HLSG-300-4200表面HLSG-300-5200切粒切刀槳片HLSG-3

23、00-6全部攪拌切刀下表面HLSG-300-72009.1.3 ZP43Tablet PressZP43旋轉(zhuǎn)式壓片機(jī)Total are 8 samples:總共8個取樣點(diǎn)：Table 5 表 5:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積下料斗表面PG16 ZP431200飼料靴表面PG16 ZP432200孔PG16 ZP433200出片器表面PG16 ZP434200除粉器表面PG16 ZP435200轉(zhuǎn)盤側(cè)面PG16 ZP43-6200底面PG16 ZP437 :200模孔表面PG

24、16 ZP4382009.1.4 HLD-1000BHLD-1000B Hopper type of ble nderHLD-1000料斗式混合機(jī)Total are 3 samples:總共3個取樣點(diǎn)：Table 6 表 6:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積加料口表面JSH-600-1200邊緣JSH-600-2200出料口表面JSH-600-32009.1.6 JZF-400 granu lators & mill JZF-400型整粒、粉碎機(jī)Total are 6

25、samples:總共6個取樣點(diǎn)：Table 8 表 8:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積蓋子表面JZF-400-1200表面JZF-400-2200容器側(cè)面JZF-400-3200底部JZF-400-4200出料口表面JZF-400-5200表面JZF-400-62009.1.7 DPP-250B blister packagi ng machi neDPP-250B型多功能自動鋁塑包裝機(jī)Total are 4 samples:總共4個取樣點(diǎn)：Table 9 表 9:Part

26、Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積加料斗側(cè)面DPP-250B-1200底部DPP-250B-2200分料刷表面DPP-250B-3200滾刷表面DPP-250B-42009.1.8 METAL DETECTOR金屬探測儀Total are 4 samples: 總共4個取樣點(diǎn)：Table 10 表 10:Part NameSampli ng Locati onSampli ng No.Swab Area Ss (cm2) 取樣面積部件名稱取樣位置取樣點(diǎn)加料斗上側(cè)面M-1200下側(cè)面M-22

27、00出料斗表面M-3200廢片出口表面M-42009.1.9 BGD-150D high-efficiency coating machine 包衣機(jī)Total are 8 samples:總共8個取樣點(diǎn)：Table 11 表 11:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積配料鍋頂部BGD-150D1200側(cè)面BGD-150D2200底部BGD-150D3200包衣鍋側(cè)面BGD-150D4200底部BGD-150D5200頂部BGD-150D6200接縫處BGD-150D7200邊緣B

28、GD-150D82009.2 Ri ngi ng sampli ng 淋洗水取樣BGD-150D high-efficie ncy coati ng mach ine包衣機(jī)Sampling location取樣部位：硅膠管、噴槍Three dimensional mixerHLD-1000B型料斗式混合機(jī)清潔操作規(guī)程Sampli ng location取樣部位：腔體For Microbes微生物取樣點(diǎn)9.3.1 JHZ -250B high shear mixer/granulatorJHZ-250B高效濕法制粒機(jī)Total are 7 samples:總共7個取樣點(diǎn)：Table 12 表 1

29、2:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積Pan制粒鍋Side側(cè)面JHZ-250B-A25Underside 底面JHZ-250B-B25出料口Inner surface 表面JHZ-250B-C25腔蓋Rim area un der the seal蓋的邊緣JHZ-250B-D25表面JHZ-250B-E25切粒切刀槳片JHZ-250B-F25攪拌切刀下表面JHZ-250B-G25ZS-650漩渦振蕩篩Total are 5 samples:總共5個取樣點(diǎn)：Table 13 表 1

30、3:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積上蓋表面ZS-650-A25篩網(wǎng)上表面ZS-650-B25出料口表面ZS-650-C25密封圈表面ZS-650-D25容器表面ZS-650-E259.3.3 Korsch PH300-36 Tablet Press KORSCH PH-300-36旋 轉(zhuǎn)式壓片機(jī)Total are 8 samples:總共8個取樣點(diǎn)：Table 14 表 14:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取

31、樣點(diǎn)Swab Area Ss (cm2) 取樣面積下料斗表面PH-300-36-A25飼料靴表面PH-300-36-B25孔PH-300-36-C25出片器表面PH-300-36-D:25除粉器表面PH-300-36-E25轉(zhuǎn)盤側(cè)面PH-300-36-F25底面PH-300-36-G25模孔表面PH-300-36-H259.3.4 Three dime nsional mixerHLD-1000B型料斗式混合機(jī)清潔操作規(guī)程Total are 3 samples:總共3個取樣點(diǎn)：Table 15 表 15:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng

32、 No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積加料口表面JSH-600-A25邊緣JSH-600-B25出料口表面JSH-600-C259.3.5 CT-C-2 Hot Air Circulati ng DrierCT-C-2型熱風(fēng)循環(huán)烘箱Total are 10 samples:總共10個取樣點(diǎn)：Table 16 表 16:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積烘盤表面CT-C-2-A 25側(cè)面CT-C-2-B25箱體左側(cè)CT-C-2-C25右側(cè)CT-C-2-D25頂

33、部CT-C-2-E25接縫處CT-C-2-F:25臺車托架CT-C-2-G25邊緣CT-C-2-H25箱門表面CT-C-2-I25密封條CT-C-2-J259.3.6 JZF-400 granu lators & mill JZF-400型整粒、粉碎機(jī)Total are 6 samples:總共6個取樣點(diǎn)：Table 17 表 17:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積蓋子表面JZF-400-A25表面JZF-400-B25容器側(cè)面JZF-400-C25底部JZF-400-

34、D25出料口表面JZF-400-E25表面JZF-400-F259.3.7 DPP-250B blister packagi ng machi neDPP-250B型多功能自動鋁塑包裝機(jī)Total are 4 samples:總共4個取樣點(diǎn)：Table 18 表 18:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積加料斗側(cè)面DPP-250B-125底部DPP-250B-2:25分料刷表面DPP-250B-325滾刷表面DPP-250B-4259.3.8 METAL DETECTOR金屬探測儀

35、Total are 4 samples:總共4個取樣點(diǎn)：Table 19 表 19:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng No.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積加料斗上側(cè)面M-A25下側(cè)面M-B:25出料斗表面M-C25廢片出口表面M-D259.3.9 BGD-150D high-efficie ncy coat ing machi ne 包衣機(jī)Total are 8 samples:總共8個取樣點(diǎn)：Table 20 表 20:Part Name部件名稱Sampli ng Locati on取樣位置Sampli ng N

36、o.取樣點(diǎn)Swab Area Ss (cm2) 取樣面積配料鍋頂部BGD-150DA25側(cè)面BGD-150DB25底部BGD-150DC25包衣鍋側(cè)面BGD-150DD25底部BGD-150DE25頂部BGD-150DF25接縫處BGD-150DG25邊緣BGD-150DH259.4 Ri ngi ng sampli ng 淋洗水取樣BGD-150D high-efficie ncy coati ng mach ine包衣機(jī)Sampling location取樣部位：硅膠管、噴槍Three dimensional mixer HLD-1000B型料斗式混合機(jī)清潔操作規(guī)程 Sampli ng l

37、ocation取樣部位：腔體10. Action taken when out-of-limit result found對不符合接受限度的測試結(jié)果所采取的措施? In spect the process of operati on檢查測試過程1.In spect the equipme nt of assay檢查分析所用的儀器2.In spect the step of operati on檢查實驗步驟3.In spect the process of sampli ng檢查抽樣過程QAQC and the product ion departme nt calculate with the

38、 results of in spect.QAQC 及生產(chǎn)部對檢查結(jié)果進(jìn)行討論Modify the validation plan; revalidate the items, which are not applicable before.11. Revalidation 再驗證Revalidation should be considered under the following circumstances: 在下列情況發(fā)生時，必須考慮是否要進(jìn)行重驗證： Cleaning method changed/ 清潔程序變化時 Cleaning detergents changed/ 清潔劑變化

39、時 Product changed/ 產(chǎn)品變化時附件 1-18附件 19 和取樣 附件 2012. Cleaning Validation Executive Record 清潔驗證過程記錄Risk Analysis Table風(fēng)險分析表Active Ingredient目檢Microbes 目檢和取樣清洗驗證棉簽取樣接受限度的計算Visual Inspection and Sampling forActive Ingredient 分析結(jié)果Microbes 分析結(jié)果 取樣回收率試驗Visual Inspection and Sampling for附件 21Analytical Result

40、s for附件 22Analytical Results for附件 23Sampling Recovery Test附件 24附件 25附件 26Swab Chacterization for Cleaning Validation 清洗驗證棉簽特性研究Swab Sampling for Cleaning Validation Calculation for Acceptance Criteria14. CONCLUSION結(jié)論The results obtained should not exceed the calculated contamination limit. The clea

41、ning procedure for all pieces of production equipment effectively removes residues of Lovastatin Tablets manufactured in this equipment and is therefore deemed validated. Microbes limit comply with the requirement.測試結(jié)果不得大于計算出的檢測限 . 設(shè)備的清潔程序可以有效清除產(chǎn)品殘留，認(rèn)為驗證有效。 微生物限度符合要求。1.1No.序號nt NameFormatA+BComp one

42、nt Name 部件名稱制粒鍋出料口腔蓋切粒切刀攪拌切刀設(shè)備名稱:JHZ-250B High Shear Mixer / GranulatorJHZ-250B高效濕法制粒機(jī)Date日期:1.2*Sam.No.取樣部位Con tactArea藥品接觸表面Inner surface 表面表面表面表面表面22.1Critica l關(guān) 鍵Yes是No 否3.1Risk forProcess Step風(fēng)險Possibility of con tam in ati on 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1.2* Sample

43、 No. see the seven sampling points on Table3.3.2Eval. of risk 風(fēng)險 評估3.3Follow-upof risk是否確認(rèn)為有風(fēng)險Yes是No 否4.1Possible cause 可能的原因Clea ning procedure of SOP is not efficie nt 清潔方法不足 夠有效Ditto 同上Ditto同上Ditto同上取樣部位：共7個取樣點(diǎn) 見表3.4.2Validati onmeasur驗證措施Check clea ning result at defi ned locati on 在規(guī)定部位檢 查清潔結(jié)果D

44、itto同上Ditto同上Ditto同上4.3 Validati on pla n 驗證計劃See validati on protocol 見清潔驗證4.4Date日期4.5Resp on sib le pers on負(fù)責(zé)人FormatA+BEquipme nt Name設(shè)備名稱：ZS-650 Vortex Oscillator/Compact Sieve Date ZS-650漩渦振蕩篩日期:12341.11.22.13.13.23.34.14.24.34.44.5*Eval.Follow-upPossibleValidati onValidati onDateResp on sibleN

45、oComp onentSam.Con tactCriticalRisk for Processofof riskcausemeasurepla n日期pers on序Name No.Area關(guān)鍵Steprisk是否確認(rèn)為可能的原因驗證措施驗證計劃負(fù)責(zé)人號部件名稱取樣藥品接觸表風(fēng)險風(fēng)險有風(fēng)險部位面評估NoYesNoYes否是否是in gredie nt 風(fēng)險分析表：設(shè)備名稱：Korsch PH300-36 Tablet Press DateKORSCH PH-300-36旋轉(zhuǎn)式壓片機(jī)日期:12345上蓋篩網(wǎng)出料口密封圈容器Inn er surface 表面Surface 表面Surface表面表

46、面表面xxxxxPossibility of con tam in ati on 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LHHMMxxxxXClea ning procedure of SOP is not efficie nt 清潔方法不足 夠有效Ditto 同上Ditto 同上Ditto 同上Ditto 同上Check clea ning result at defi ned locati on 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 va

47、lidati on protocol 見 清潔驗證方 案1.2 * Sample No. see five sampling points on Table 4.取樣部位：共 5 個取樣點(diǎn)見 表 4.Attachment 附件 3: Risk Analysis Table for activent NameFormat1231.11.2*2.13.13.23.3Sam.Con tactCriticaRisk forEval.Follow-upNoComp onentNo.ArealProcess Stepof riskof riskName取樣藥品接觸表關(guān)風(fēng)險風(fēng)險是否確認(rèn)為序部件名稱部位面鍵評

48、估有風(fēng)險號YesNoYesNo是否是否4.1Possible cause 可能的原因4.2Validati on measur 驗證措施4.3Validati onpla n驗證計劃4.4Date日期A+B12345Hopper下料斗飼料靴出片器除粉器 壓片室隔板Inn er surface 表面表面及孔表面表面表面XXXXXPossibility of con tam in ati on with previous product 與前批產(chǎn)品交叉污 染的可能性Ditto 同上DittoMHMMLxxxXXClea ning procedure of SOP is not efficie nt 清潔方法不足 夠有效Ditto 同上Ditto 同上Check clea ning result at defi ned locati on 在規(guī)定部位檢 查清潔結(jié)果Ditto 同上DittoSee validati on protocol 見清潔驗