欧盟清洁验证方案(带风险分析)

1、Subject/主题LovastatinTablets20mgCleaningValidationProtocol鲨鱼软骨片清洁验证方案文件编号：Tableofcontents目录Responsibility职责Purpose目的Frequency周期RelevantSOPs相关的SOPsEquipment设备TestMethod测试方法AcceptanceCriteria接受限度RiskAnalysis风险分析SamplingPlan抽样计划Actiontakenwhenout-of-limitresultfound对不符合接受限度的测试结果所采取的措施Revalidation再验证Clea

2、ningValidationExecutiveRecord清洁验证过程记录Conclusion结论Attachments附件Writtenby:制订者：Date:日期：Reviewedby:复核者：Date:日期：Approvedby:批准者：Date:日期：Approvedby:批准者：Date:日期：Responsibility职责QAisresponsibleforplanthecleaningvalidation.QA负责整个清洁验证的安排QCisresponsibleforsamplingandanalysis.QC负责抽样及测试ProductionDepartmentisrespo

3、nsibleforperformingcleaningproductionequipment.生产部负责设备的清洁.Purpose目的ThepurposeofthiscleaningvalidationprotocolistodemonstratethatthecleaningprocedureusedtocleanJHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress,BGD-150

4、Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachinecaneffectivelyremoveresiduesoftheproductsmanufacturedinZS-650VortexOscillator/CompactSieve,JHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress,BGD-150Dhig

5、h-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinetoapredeterminedlevelthatdoesnotraiseanysafetyconcerns.清洗验证方案的目的是证明JHZ-250B高效湿法制粒机、HLD-1000B型料斗式混合机清洁操作规程、CT-T-II型热风循环烘箱、JZF-400型整粒、粉碎机、KorschPH-300-36旋转式压片机、BGD-150D型高效包衣机和DPP-250B型多功能自动铝塑包装所使用的清洗程序能够有效地除去产品残留，达到预先确定的限度，从而达到对下批产品无影响。Freque

6、ncy周期ThecleaningvalidationstudyisperformedafterthreeconsecutivemajorcleaningsofZS-650VortexOscillator/CompactSieve,JHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bbli

7、sterpackagingmachineafterthemanufactureofLovastatinTablets.连续三批生产后，进行清洗验证研究。RelevantSOP相关的SOPsSOP-PD-304-00CleaningprocedureforHLSG-300HighSpeedMixer/GranulatorHLSG-300型高效湿法混合制粒机清洁操作规程SOP-PD-304-00CleaningprocedureforLF120E-Bairpillow-dryGranulatorLF120E-B型沸腾干燥制粒机清洁操作规程SOP-PD-310-00Cleaningprocedure

8、forZP43HighSpeedrotarytabletpress高效ZP43旋转式压片机清洁操作规程SOP-PD-307-00CleaningprocedureforHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机清洁操作规程SOP-PD-306-00CleaningprocedureforYK-160granulatorsYK-160整粒机清洁操作规程SOP-PD-311-00CleaningprocedureforBG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机清洁操作规程SOP-PD-313-00

9、CleaningprocedureforDPH-130、DPP-250BblisterpackagingmachineDPH-130、DPP-250型铝塑袍罩包装机清洁操作规程ESS-VD007Validationguideline-cleaning验证指南-清洁验证ESS-VD011Surfacesamplingforcleaningvalidation清洗验证设备表面取样|ESS-VD014Selectionoftheworstcaseincleaningvalidation清洁验证中最坏情况的选择SOP-QC-1075检验操作规程ESS-GM066|MicrobeTest微生物限度检测法

10、5.Equipments设备No.序号EquipmentNo.设备编号EquipmentName设备名称ProductContactSurfaceArea与产品接触面积（m2）1HLSG-300highspeedmixer/granulatorHLSG-300高效湿法混合制粒机2.81LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器5.903ZP43TabletPressZP43旋转式压片机64METALDETECTOR金属探测仪0.35HLD-1000BHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机5.2

11、56YK-160granulatorsYK-160型整粒机0.377DPH-130DPP-250blisterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机1.08BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机8.43TotalProductContactSurfaceArea（m2）与产品接触面积总和（m2）99.62ListofEquipment设备清单ThelistofEquipmentusedinthemanufactureofLovastatinTablets:有关鲨鱼软骨片生产线的所有机器列出

12、如下：HLSG-300highspeedmixer/granulatorHLSG-300高效湿法混合制粒机LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器ZP43TabletPressZP43TabletPressP43旋转式压片机METALDETECTOR金属探测仪HLD-1000BHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机YK-160granulatorsYK-160型整粒机DPH-130DPP-250blisterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机

13、BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机Table1表1:5.2ValidationScope验证范围HLSG-300highshearmixer/granulatorHLSG-300高效湿法制粒机LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器ZP43TabletPressZP43旋转式压片机METALDETECTOR金属探测仪HLD-1000BgranulemixerHLD-1000B型料斗式混合机YK-160granulatorsYK-160型整粒机DPH-130、DPP-250bli

14、sterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机TestMethod测试方法Thecleaningvalidationstudiesarebasedontheswabbingtechniqueandrinsingsampling.Theselectedswabsshouldbecharacterizedfortheirsuitabilityandarecoverytestshouldbeperformedpriortothevalidationstudi

15、es.Thevalidationstudiesincludeswabbingofthemainsurfaceareaaswellasthehard-to-cleanlocations.Swabbingandringingiscarriedoutfortheactiveingredient.清洁验证研究用擦拭取样法和最终淋洗水取样。验证研究之前，选择的棉签的特性应适合并进行回收率研究。验证研究包括主要表面积和难清洁部位的擦拭。对活性成分擦拭取样和淋洗水取样。SamplingMethod抽样方法SwabSampling擦拭法Ringingsampling最终淋洗水取样法AcceptanceCrit

16、eria接受限度VisualInspection目测检查AcceptanceCriteria接受限度Thereisnovisibleresidueinequipmentsurfaceaftercleaning.设备在清洁后，无可见的物质残留在设备表面AcceptanceCriteriaofmicrobe微生物测试接受限度Forswabsamples对擦拭样品：Microbes微生物含量：2CFU/cm2,即50CFU/25cm2Forrinsingsamples/对冲淋样品：Microbes微生物含量：100CFU/mlAcceptanceCriteriaofassay化学测试接受限度Acti

17、veIngredient(seeAttachment26)活性成分(见附件26)MC(mg/swab)=0.0843(Active)Forrinsingsamples对冲淋样品：MC(mg/L)=0.084(Active)Testfrequency检测次数ThecleaningvalidationstudiesareconductedafterthreeconsecutivemajorcleaningsofNourkrinTablets.三批鲨鱼软骨片生产结束后进行清洗验证。RiskAnalysis风险分析Theresiduesoftheproductsarenotdistributeduni

18、formity,sotheriskanalysisshouldbedonebeforecleaningvalidationsampling.TheCriticallocationwillbedeterminedatriskanalysis.RiskanalysesaresummarizedinAttachment1andAttachment18.由于上一产品生产对下一产品的污染并不是均匀分布在整个设备的接触面上，因此清洁验证的活性成分抽样计划的确定必须先进行风险分析，且在风险分析中确定清洁验证的关键部位。风险分析见附件1到附件18:风险分析表SamplingPlan抽样计划Foractivei

19、ngredient活性成分Swabsampling擦拭法Thefollowinglocationwillbesampledasriskanalysis:根据风险分析，在下列抽样部位取样：HLSG-300highshearmixer/granulatorHLSG-300高效湿法混合制粒机Totalare7samples:总共7个取样点：Table3表3:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积PanSide侧面HLSG-300-1200制粒锅Underside底囿HLSG-300-2200出料口Inners

20、urface内表囿HLSG-3003200腔盖Rimareaundertheseal盖的边缘HLSG-300-4200内表向HLSG-300-5200切粒切刀桨片HLSG-300-6全部搅拌切刀卜表面HLSG-300-7200ZP43TabletPressZP43旋转式压片机Totalare8samples:总共8个取样点：Table5表5:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积下料斗内表向PG16、ZP43-11200饲料靴表向PG16、ZP43-2200孔PG16、ZP43-31200出片器内表向P

21、G16、ZP43-4200除粉器内表向PG16、ZP43-5200转盘侧面PG16、ZP43-6200底向PG16、ZP43-7200模孔内表向PG16、ZP43-8200HLD-1000BHLD-1000BHoppertypeofblenderHLD-1000料斗式混合机Totalare3samples:总共3个取样点：Table6表6:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积加料口内表向JSH-600-1200边缘JSH-600-2200出料口内表向JSH-600-3200JZF-400granula

22、tors&millJZF-400型整粒、粉碎机Totalare6samples:总共6个取样点：Table8表8:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积盖子内表向JZF-400-1200内表向JZF-400-2200容器内侧面JZF-400-3200内底部JZF-400-4200出料口表向JZF-400-5200表向JZF-400-6200DPP-250BblisterpackagingmachineDPP-250B型多功能自动铝塑包装机Totalare4samples:总共4个取样点：Table9表9

23、:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积加料斗侧面DPP-250B-1200底部DPP-250B-2-200分料刷表向DPP-250B-3200滚刷表向DPP-250B-4200METALDETECTOR金属探测仪Totalare4samples:总共4个取样点：Table10表10:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积加料斗上侧面M-1200下侧面M-2200出料斗内表向M-3200废片出口内表向M-4200

24、BGD-150Dhigh-efficiencycoatingmachine包衣机Totalare8samples:总共8个取样点：Table11表11:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积配料锅顶部BGD-150D-1200侧面BGD-150D-2200底部BGD-150D-3200包衣锅侧面BGD-150D-4200底部BGD-150D-5200顶部BGD-150D-6200接缝处BGD-150D-7200边缘BGD-150D-82009.2Ringingsampling淋洗水取样BGD-150Dh

25、igh-efficiencycoatingmachine包衣机Samplinglocation取样部位：硅胶管、喷枪ThreedimensionalmixerHLD-1000B型料斗式混合机清洁操作规程Samplinglocation取样部位：腔体ForMicrobes微生物取样点JHZ-250Bhighshearmixer/granulatorJHZ-250B高效湿法制粒机Totalare7samples:总共7个取样点：Table12表12:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积Pan制粒锅Side

26、侧面JHZ-250B-A25Underside底面JHZ-250B-B125出料口Innersurface内表囿JHZ-250B-C25腔盖Rimareaundertheseal盖的边缘JHZ-250B-D25内表向JHZ-250B-E25切粒切刀桨片JHZ-250B-F25搅拌切刀卜表面JHZ-250B-G25ZS-650VortexOscillator/CompactSieveZS-650漩涡振荡筛Totalare5samples:总共5个取样点：Table13表13:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)

27、取样面积上盖内表向ZS-650-A25筛网上表向ZS-650-B25出料口内表向ZS-650-C125密封圈内表向ZS-650-D25容器内表向ZS-650-E25KorschPH300-36TabletPressKORSCHPH-300-36旋转式压片机Totalare8samples:总共8个取样点：Table14表14:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积下料斗内表向PH-300-36-A25饲料靴表向PH-300-36-B25孔PH-300-36-C25出片II内表向PH-300-36-D25

28、除粉器内表向PH-300-36-E25转盘侧面PH-300-36-F25底向PH-300-36-G25模孔内表向PH-300-36-H259.3.4ThreedimensionalmixerHLD-1000B型料斗式混合机清洁操作规程Totalare3samples:总共3个取样点：Table15表15:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积加料口内表向JSH-600-A25边缘JSH-600-B25出料口内表向JSH-600-C25CT-C-2HotAirCirculatingDrierCT-C-2型

29、热风循环烘箱Totalare10samples:总共10个取样点：Table16表16:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积Ba表向CT-C-2-A25内侧面CT-C-2-B125箱体左侧CT-C-2-C25右侧CT-C-2-D125顶部CT-C-2-E25接缝处CT-C-2-F25台车托架CT-C-2-G25边缘CT-C-2-H25箱门内表向CT-C-2-I25密封条CT-C-2-J25JZF-400granulators&millJZF-400型整粒、粉碎机Totalare6samples:总共6

30、个取样点：Table17表17:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积盖子内表向JZF-400-A25内表向JZF-400-B25容器内侧面JZF-400-C25内底部JZF-400-D25出料口表向JZF-400-E25表向JZF-400-F25DPP-250BblisterpackagingmachineDPP-250B型多功能自动铝塑包装机Totalare4samples:总共4个取样点：Table18表18:PartName部件名称SamplingLocation取样位置SamplingNo.取

31、样点SwabAreaSs(cm2)取样面积加料斗侧面DPP-250B-125底部DPP-250B-2-25分料刷表向DPP-250B-325滚刷表向DPP-250B-425METALDETECTOR金属探测仪Totalare4samples:总共4个取样点：Table19表19:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积加料斗上侧面M-A25下侧面M-B25出料斗内表向M-C25废片出口内表向M-D25BGD-150Dhigh-efficiencycoatingmachine包衣机Totalare8samp

32、les:总共8个取样点：Table20表20:PartName部件名称SamplingLocation取样位置SamplingNo.取样点SwabAreaSs(cm2)取样面积配料锅顶部BGD-150D-A25侧面BGD-150D-B25底部BGD-150D-C25包衣锅侧面BGD-150D-D25底部BGD-150D-E25顶部BGD-150D-F25接缝处BGD-150D-G25边缘BGD-150D-H259.4Ringingsampling淋洗水取样BGD-150Dhigh-efficiencycoatingmachine包衣机Samplinglocation取样部位：硅胶管、喷枪Thr

33、eedimensionalmixerHLD-1000B型料斗式混合机清洁操作规程Samplinglocation取样部位：腔体Actiontakenwhenout-of-limitresultfound对不符合接受限度的测试结果所采取的措施?Inspecttheprocessofoperation检查测试过程Inspecttheequipmentofassay检查分析所用的仪器Inspectthestepofoperation检查实验步骤Inspecttheprocessofsampling检查抽样过程?QA,QCandtheproductiondepartmentcalculatewitht

34、heresultsofinspect.QA,QC及生产部对检查结果进行讨论?Modifythevalidationplan;revalidatetheitems,whicharenotapplicablebefore.修改验证计划，对不符合的项目进行重验证。Revalidation再验证Revalidationshouldbeconsideredunderthefollowingcircumstances:在下列情况发生时，必须考虑是否要进行重验证：Cleaningmethodchange删洁程序变化时Cleaningdetergentschanged方洁剂变化时Productchanged产

35、品变化时CleaningValidationExecutiveRecord清洁验证过程记录附件1-18RiskAnalysisTable风险分析表附件19VisualInspectionandSamplingforActiveIngredient目检和取样附件20VisualInspectionandSamplingforMicrobes目检和取样附件21AnalyticalResultsforActiveIngredient分析结果附件22AnalyticalResultsforMicrobes分析结果附件23SamplingRecoveryTest取样回收率试验附件24SwabChacte

36、rizationforCleaningValidation清洗验证棉签特性研究附件25SwabSamplingforCleaningValidation清洗验证棉签取样附件26CalculationforAcceptanceCriteria接受限度的计算14.CONCLUSION结论Theresultsobtainedshouldnotexceedthecalculatedcontaminationlimit.ThecleaningprocedureforallpiecesofproductionequipmenteffectivelyremovesresiduesofLovastatinTa

37、bletsmanufacturedinthisequipmentandisthereforedeemedvalidated.Microbeslimitcomplywiththerequirement.测试结果不得大于计算出的检测限.设备的清洁程序可以有效清除产品残留，认为验证有效。微生物限度符合要求。Attachment附件1:RiskAnalysisTableforactiveingredient风险分析表FormatA+BDate日期:EquipmentName设备名称:JHZ-250BHighShearMixer/GranulatorJHZ-250B高效湿法制粒机1T2341.1No.序

38、号ComponentName部件名称1.2*Sam.No.取样部位ContactArea药品接触表面2.1Criti关键cal3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Follcofri是否也有Jw-upsk角认为4险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人Yes是No否Yes是No否1制粒锅Innersurface2出料口内表向内表面XXPossibilityofcontaminationwit

39、hpreviousproduct与前批产品交叉污染的可能性MMXxCleaningprocedureofSOPisnotefficient清洁方法不足够功效Checkcleaningresultatdefinedlocation在规定部位检查清洁结果Seevalidationprotocol见清洁验证力杀3腔盖内表向Ditto同上MxDitto同上Ditto同上XDitto同上Ditto同上Ditto同上4切粒切刀表面XDitto同上HxDitto同上Ditto同上5搅拌切刀表面HX1.2*SampleNo.seethesevensamplingpointsonTable3.取样部位：共7个取

40、样点见表3.Attachment附件2:RiskAnalysisTableforactiveingredient风险分析表FormatA+BEquipmentName设备名称：ZS-650VortexOscillator/CompactSieveDate日期：ZS-650漩涡振荡筛1234i.i1.22.1Critical关键3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Follow-upofrisk是否确认为4.1Possiblecause可能的原因4.2Validationmeasure验证措施4.3Validationplan验证计划4.4Dat

41、e日期4.5Responsibleperson负责人No序号ComponentName部件名称*Sam.No.取样部位ContactArea药品接触表面Yes是No否Yes是No否12345上盖筛网出料口密封圈容器Innersurface内表面Surface表面Surface内表面内表面内表面xxxxxPossibilityofcontaminationwithpreviousproduct与前批产品交叉污染的可能性Ditto同上Ditto同上Ditto同上Ditto同上LHHMMxxxxXCleaningprocedureofSOPisnotefficient清洁方法不足够功效Ditto同上

42、Ditto同上Ditto同上Ditto同上Checkcleaningresultatdefinedlocation在规定部位检查清洁结果Ditto同上Ditto同上Ditto同上Ditto同上Seevalidationprotocol见清洁验证方案1.2*SampleNo.seefivesamplingpointsonTable4.取样部位：共5个取样点见表4.Attachment附件3:RiskAnalysisTableforactiveingredient风险分析表FormatA+BEquipmentName设备名称:KorschPH300-36TabletPressDate日期：KORS

43、CHPH-300-36旋转式压片机TI2341.1No.序号ComponentName部件名称1.2*Sam.No.取样部位ContactArea药品接触表面2.1Criti关键cal3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Folloofr是否彳有J)w-upsk涌认为双险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人Yes是No否Yes是No否1Hopper下料斗Innersurface内表面XPo

44、ssibilityofcontaminationMxCleaningprocedureofCheckcleaningresultatdefinedSeevalidation23456饲料靴出片器除粉器压片室隔板转盘表向及孔表面内表面表面表面XXXXXwithpreviousproduct与前批产品交叉污染的可能性Ditto同上Ditto同上DittoHMMLMxxXXXSOPisnotefficient清洁方法不足够功效Ditto同上Ditto同上Ditto同上location在规定部位检查清洁结果Ditto同上Ditto同上Ditto同上protocol见清洁验证力杀7内表白X同上LX冲头和

45、冲模Ditto同上Ditto同上8内表面XHX模孔1.2*SampleNo.seetheeightsamplingpointsonTable5.取样部位：共8个取样点见表5.FormatA+BEquipmentName设备名称:ThreedimensionalmixerDate日期:HLD-1000B型料斗式混合机清洁操作规程Tl2341.11.2*2.13.13.23.34.14.24.34.44.5No.序号ComponentName部件名称Sam.No.取样部位ContactArea药品接触表面Criti关键calRiskforProcessStep风险Eval.ofrisk风险评估Fo

46、lloofr是否彳有J)w-upsk诵认为双险Possiblecause可能的原因Validationmeasur验证措施Validationplan验证计划Date日期Responsibleperson负责人Yes是No否Yes是No否加料口InnersurfaceXPossibilityofMxCleaningCheckcleaningSee123出料口腔体内表向Innersurface内表面Innersurface内表面XXcontaminationwithpreviousproduct与前批产品交叉污染的可能性Ditto同上MHxxprocedureofSOPisnotefficien

47、t清洁方法不足够功效Ditto同上Ditto同上resultatdefinedlocation在规定部位检查清洁结果Ditto同上Ditto同上validationprotocol见清洁验证力杀1.2*SampleNo.seethethreesamplingpointsonTable6.取样部位：共3个取样点见表6.Attachment附件5:RiskAnalysisTableforactiveingredient风险分析表：FormatA+BEquipment Name设备名称:CT-C-2 Hot Air Circulating DrierCT-C-2型热风循环烘箱231.11.2*2.1

48、3.13.2N o. 序 号Component Name 部件名称Sam.No.取样 部位Contact Area 药品接触表 面Criti关 键calRisk for ProcessStep风险Eval. of risk 风险 评估Yes 是No否BaSurfaceXPossibility ofM1表向contamination2箱体Inner surface内表面Xwith previous product与前批产品交叉污 染的可能性HDitto34台车箱门Surface表面Inner surface 内表面XX同上Ditto 同上Ditto 同上MHDate日期:43.3 Follow-

49、up of risk是否确认为 有风险4.1Possible cause可能的原因4.2Validation measur 验证措施4.3 Validation plan 验证计划4.4Date日期4.5Responsibl e person 负责人Yes 是No否xxxXCleaning procedure of SOP is not efficient 清洁方法不足够功效Ditto 同上Ditto 同上Ditto 同上Check cleaning result at defined location 在规定部位检 查清洁结果Ditto 同上Ditto 同上Ditto 同上See valid

50、ation protocol 见清洁验证 力杀1.2*SampleNo.seethetensamplingpointsonTable7.取样部位：共10个取样点见表7.112341.11.2*2.1Critical关键3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Follow-upofrisk是否确认为有风险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人No.序号ComponentName部件名称Sam.N

51、o.取样部位ContactArea药品接触表面Yes是No否Yes是No否12345筛网斗和筛网叶轮料斗、料斗盖XXXXXPossibilityofcontaminationwithpreviousproduct与前批产品交叉污染的可能性Ditto同上Ditto同上Ditto同上MHMHHxxxXXCleaningprocedureofSOPisnotefficient清洁方法不足够功效Ditto同上Ditto同上Ditto同上Ditto同上Checkcleaningresultatdefinedlocation在规定部位检查清洁结果Ditto同上Ditto同上Ditto同上Ditto同上Se

52、evalidationprotocol见清洁验证力杀2005.1.28QA1.2*SampleNo.seethesixsamplingpointsonTable8.取样部位：共6个取样点见表8.FormatA+BEquipment Name 设备名称：JZF-400 granulators & millJZF-400型整粒、粉碎机Date日期:FormatA+BEquipmentName设备名称DPP-250BblisterpackagingmachineDPP-250B型多功能自动铝塑包装机Date日期:2341.11.2*2.13.13.23.34.14.24.34.44.5No.序号Co

53、mponentName部件名称Sam.No.取样部位ContactArea药品接触表面Criti关键calRiskforProcessStep风险Eval.ofrisk风险评估Follcofr是否彳有J)w-upsk诵认为双险Possiblecause可能的原因Validationmeasur验证措施Validationplan验证计划Date日期Responsibleperson负责人Yes是No否Yes是No否加料斗InnersurfaceXPossibilityofMxCleaningCheckcleaningSee2005.1.28QA12分料刷内表向Surface表面Xcontami

54、nationwithpreviousproduct与前批产品交叉污染的可能性MxprocedureofSOPisnotefficient清洁方法不足够功效resultatdefinedlocation在规定部位检查清洁结果validationprotocol见清洁验证力杀3滚刷Surface表面XDitto同上Ditto同上MxXXDitto同上Ditto同上Ditto同上Ditto同上1.2*SampleNo.seethefoursamplingpointsonTable9.取样部位：共4个取样点见表9.FormatA+BDate日期:EquipmentName设备名称:METALDETEC

55、TOR金属探测仪112341.11.2*2.1Critical关键3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Follow-upofrisk是否确认为有风险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人No.序号ComponentName部件名称Sam.No.取样部位ContactArea药品接触表面Yes是No否Yes是No否123加料斗出料斗废片出口Innersurface内表面Innersurfac

56、e内表面Innersurface内表面XXXPossibilityofcontaminationwithpreviousproduct与前批产品交叉污染的可能性Ditto同上Ditto同上MMMxxxCleaningprocedureofSOPisnotefficient清洁方法不足够功效Ditto同上Ditto同上Checkcleaningresultatdefinedlocation在规定部位检查清洁结果Ditto同上Ditto同上Seevalidationprotocol见清洁验证力杀2005.1.28QA1.2*SampleNo.seethefoursamplingpointsonTa

57、ble10.取样部位：共4个取样点见表10.EquipmentName设备名称:BGD-150Dhigh-efficiencycoatingmachineDate日期:F0rmat包衣机A+B112341.11.2*2.1Critical关键3.1RiskforProcessStep风险3.2Eval.ofrisk风险评估3.3Follow-upofrisk是否确认为有风险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人No.序号ComponentN

58、ame部件名称Sam.No.取样部位ContactArea药品接触表面Yes是No否Yes是No否12345配料锅包衣锅硅胶管喷枪Innersurface内表面SurfaceandholeXXXXXPossibilityofcontaminationwithpreviousproduct与前批产品交叉污染的可能性Ditto同上Ditto同上Ditto同上MHMHHxxxXXCleaningprocedureofSOPisnotefficient清洁方法不足够功效Ditto同上Ditto同上Ditto同上Ditto同上Checkcleaningresultatdefinedlocation在规定

59、部位检查清洁结果Ditto同上Ditto同上Ditto同上Ditto同上Seevalidationprotocol见清洁验证力杀2005.1.28QA表向及孔Surface表面Surface表面Surface表面1.2*SampleNo.seetheeightsamplingpointsonTable11.取样部位：共8个取样点见表11.FormatA+B-EquipmentName设备名称：JHZ-250BHighShearMixer/GranulatorDate日期：JHZ-250B高效湿法制粒机1T2341.11.2*2.1Critical关键3.1RiskforProcessStep风

60、险3.2Eval.ofrisk风险评估3.3Follow-upofrisk是否确认为有风险4.1Possiblecause可能的原因4.2Validationmeasur验证措施4.3Validationplan验证计划4.4Date日期4.5Responsibleperson负责人No.序号ComponentName部件名称Sam.No.取样部位ContactArea药品接触表面Yes是No否Yes是No否12345制粒锅出料口腔盖切粒切刀搅拌切刀Innersurface内表面内表面内表面表面表面XXXXPossibilityofcontaminationwithpreviousproduc