洁净室风险评估 Risk Assessment of Clean Room

洁净室风险评估Risk Assessmentof Clean Room作者Author姓名公司签名日期Print NameCompany Signature Date审核Reviewer姓名公司/部门签名日期Print NameCompany/Department SignatureDate批准Approver姓名公司/部门签名日期Print NameCompany/SignatureDate中Medium2认为缺陷状况的检测是很可能的例如，在每发生次检测到次21It is considered possible to detectdefect conditionsfor example,1in every2occurrences.认为缺陷状况的检测是非常可能的例如，每次发生可检测到次1高High1The detectionof defectconditions isconsidered highlyprobable for example,it can bedetected1time peroccurrence.风险优先性计算为将各不同因素进行相乘公式为风险优先性=严重性*可能性*可检测性The RPNis calculatedby multiplyingdifferent factors:the formulais RPN=S*P*D.风险优先性（）描述RPN Describe身风险水平此为不可接受风险必须尽快米用控制措施，通过提高可检测性及降低风险产生的可能性来降低最终风险水平验证应先集中于确认已采用控制措施且持续执行当RPN9High risklevel:This isan unacceptablerisk.Control measuresmust beadopted assoon asWhenRPN9possibleto reduce thefinal levelof riskby increasingdetectability andreducing the likelihoodof riskgeneration.Validation shouldinitially focuson confirmingthat control measures areinplace and are beingcontinued.中等风险水平此风险要求米用控制措施，通过提图可检测性及或降低风险产生的当6RPN9可能性来降低最终风险水平Moderate levelof risk:This riskrequires theuse ofcontrolWhen6RPNW9measures toreduce theultimate levelof riskby increasingdetectability and/or reducingthelikelihood that the riskwill arise.低风险水平此风险水平为可接受，无需采用额外的控制措施当RPN6Low levelof risk:This levelof riskis acceptableand does not requireadditional controlWhenRPN6measures.评估的目的，是每个关键部件将根据其所执行的功能而确定其最高的风险优先级别当风险优先性小于时为风险可控，6则不再给出建议措施风险优先性大于等于必须给出合理建议，并决定适宜的控制方法6The purposeof theassessment isthat eachcritical componentwill determineits highestrisk prioritybased on the functionit performs.When the risk priorityis less than6,the riskis controllable,and norecommended measuresare given.Reasonable suggestionsmust be给出建议措施之后再次对可能性、严重性和可检测made andappropriate controlmethods should be determinedfor theRPN

26.性进行评估，得到风险优先性After theproposed measuresare given,the likelihood,severity anddetectability areevaluated againto obtain the risk priority.需对建议风险控制措施进行评论Suggested riskcontrolmeasuresshouldbecommented on.文件编号/Code.版本号/Version页码/PageRA-CR-010111/

338.功能/部件关键性评估Critical evaluationof functions/components

8.1功能/部件关键性矩阵Function/component criticalmatrix问题Problem序号功能/部件组件功能关键Critical是/否NO.Function/Component Componentfunctions（Yes/NO）A BC DE FG提供送风功能段框架结构Provide air1组合式空调机箱supply functionsection framestructure N N N N N N N NOCombined air conditioning case加湿蒸汽为洁净室空调加湿2N N Y N N YESWetsteamHumidifythecleannx）mairconditionerY Y用于空调系统温度调节空调热水3Used fbrlemperature regulationof airN N N N Y YESAir conditioning hotwaterconditioning systemY Y用于空调系统温度调节空调冷水4Used fortemperature regulationof airN N Y Y N N Y YESAirconditionin®cold waterconditioning system电力供应为空调系统提供动力5N N Y Y N N Y YESPower supply Powerthe air conditioning system实现电器的启停6开关Switch Realizethe startand stopof electricalappliancesN N N N N N N NO电源接口7插座SocketThe powerinterfaceN N N N N N N NO洁净灯具为生产区域提供照明8N N N NClean lamps and lanterns Providelighting fbrproduction areaN N Y YES洁净室人员安全要求应急灯9Clean roompersonnel safetyEmergencylightrequirementsN N N N N N N NO洁净室风险评估Risk Assessmentof Clean Room文件编号/Code.版本号/Version页码/PageRA-CR-010112/33问题Problem序号功能/部件组件功能关键CriticalNO.Function/Component Componentfunctions是/否（Yes/NO）A BC DE FG洁净室功能分割10墙面和吊顶彩钢板Clean roomfunction segmentationWall and ceiling color steelplateN N N N N N Y YES洁净室门、窗户和安全门Clean洁净室内人员流动和观察il roomdoors,Windows andClean roompersonnel flowandsecurity doorsobservationN N N N NN Y YES洁净室地面要求12地面GroundClean roomfloor requirementsNNNNNNY YES用于洁净室内排水，隔绝空气防止下水道中空气反流入洁净室地漏13It isused fordean roomdniinage toFloor drainisolate airand prevent air from sewerN NNNNNY YESfromflowing backinto clean room用于密封洁净室内缝隙14密封SealUsed forsealing cracks in clean roomsN NNNNNY YES用于洁净送风过滤净化，保证房间满足净化要求高效过滤器15Used for clean air filtration andHigliefficiency filterpurification,to ensurethat the roomN Y YY NNY YESmeets the requirements of purification保证房间满足洁净度，压差及自净的设计要求送、回、排风口16Ensure that the roommeets thedesignSend,return,exhaust airoutletrequirements of cleanliness,differentialN NNNNNY YESpressureand self-cleaning.提供排风功能段框架结构排风机箱17Provides theexhaust functionsection NNNNNNNNOExhaust fanboxframe structure文件编号/Code.版本号/Version页码/PageRA-CR-010113/33问题Problem序号功能/部件组件功能关键CriticalNO.Function/Component Componentfunctions是/否（Yes/NO）A BC DE FG为洁净室送、回、排风需要18风管Duct For clean room to send,return,exhaustair needsNNNNNNY YES用于避免结露或热损耗的风险风管保温19To avoidthe riskof condensation or heatDuct insulationlossN NNNNNY YES风阀，包括定风量调节阀、变风量调节阀和手动调节阀The airvalve comprises aconstant air用于调节风量20volume regulatingvalve,aUsed forregulating air volumevariable airvolume regulatingNNYY NNYYESvalve anda manual regulatingvalve用于洁净送风及送风均匀21高效过滤器静压箱Plenum Used for cleanair supplyand uniformairchamber forhigh efficiencyfilter supplyNY NY NNYYES功能Function控制洁净室温湿度温湿度22Control clean room temperature andTemperature and humidityhumidity控制洁净室压差NYY NY NYYES23压差Control the differential pressurein theDifferential pressure clean roomN YYNYNYYES控制洁净室的自净能力24换气次数Control theself-cleaning capacity of theAir changes clean roomN YYNNNYYES悬浮粒子、微生物（沉降菌、浮控制洁净室洁净度和微生物环境25游菌/表面微生物）Suspended Control clean roomcleanliness andparticles,microbial environmentNYYNYNYYES文件编号/Code.版本号/Version页码/PageRA-CR-010114/33序号功能/部件组件功能问题Problem关键CriticalNO.Function/Component Componentfunctions是/否Yes/NOA BC DE FGmicroorganisms sedimentationbacteria,plankton/surfacemicroorganisms保护操作人员听力安全，保证生产过程中的正常沟通噪音26To protectthe hearingsafety ofoperatorsNoiseand ensure the normalcommunicationN NNNNNY YESduring production为洁净室房间提供照明亮度，保证生产人员的视线照度27Provide illuminationforclean room roomIlluminationandensure theline ofsight ofproductionN NNNNNY YESpersonnel文件编号/Code.版本号/Version页码/PageRA-CR-010115/

338.2关键性部件/功能风险评估和控制矩阵Critical component/function risk assessment andcontrol matrix关键性部件/功能风险评估矩阵Critical component/function risk assessment matrix功能/关键部件风险优序号说明/任务失效事件最差情况影响Functional/key S P D先性NO.Description/T asksFailure events Worst-case impactcomponentsRPN加湿蒸汽为洁净室空调加湿蒸汽压力不满足要求影响洁净室的湿度132212Wet steamHumidify the clean roomair The steam pressure does not meet theAffects thehumidity in the clean roomconditioner requirementsPressure is not enough影响洁净室的温湿度压力不满足要求Pressure is notenoughAffects the temperature andhumidity of39212用于空调系统温度调节空调热水the clean roomUsed fortemperature2Air conditioninghotregulation of air conditioningwater温度不满足要求影响洁净室的温湿度system32212The temperaturedoes not meet theAffects thetemperature andhumidity ofrequirements the clean room影响洁净室的温湿度压力不满足要求Affects hetemperature andhumidity of32212用于空调系统温度调节空调冷水Pressure is not enoughthe clean roomUsedfbr temperature3Air conditioningcoldregulation of air conditioningwater温度不满足要求影响洁净室的温湿度system39212The temperaturedoes not meet theAffects thetemperature andhumidity ofrequirements the clean room超过变频器工作范围的电压波动可能导致变频器和电机的损坏或无法正常使用电力供应为空调系统提供动力Power电压过低/高Voltage fluctuationsbeyond the42228Power supplythe air conditioning systemVoltage istoo low/high operatingrange of the frequencyconvertermay causedamage to thefrequency converterand motoror failuretooperate properly洁净灯具为生产区域提供照明洁净灯具不合格或布局不合理造成房间房间照度不足，影响操作人员的操作52228Clean lampsand Providelighting for照度不足精度洁净室风险评估Risk Assessmentof Clean Room文件编号/Code.版本号/Version页码/PageRA-CR-010116/33功能/关键部件风险优序号说明/任务失效事件最差情况影响Functional/key S P D先性NO.Description/Tasks Failure events Worst-case impactcomponentsRPNlanternsproduction areaClean lampsare unqualifiedor Roomillumination isinsufficient,unreasonable layout resulting inaffecting theoperation accuracyof theinsufficientroom illuminationoperator材质脱落腐蚀，影响洁净室环境材质不符合9Material sheddingcorrosion,affecting298Material does not matchAMthe clean room environment墙面和吊顶彩钢板洁净室功能分割Cleanroom墙板和顶板等连接处等未使用导角或过存在缝隙，容易滋生微生物，引起环境6Wallandceiling colorfunctionsegmentation渡材料污染steel plateNo guide Angle or transitionmaterial isThe existenceof gaps,easy tobreed2228used atthe jointssuch aswall panel and topmicroorganisms,cause environmentalplatepollution洁净室门、窗户和安全门洁净室内人员流动和观察材质不符合要求材质脱落腐蚀，影响洁净室环境7Clean roomdoors,Clean roompersonnel flowThe material does not meet theMaterial sheddingcorrosion,affecting2228Windows andsecurity andobservation requirements the clean room environmentdoors材质脱落，易被腐蚀，影响洁净室环境材质不符合要求The material falls off and iseasy to be洁净室地面要求Cleanroom8地面Ground The material docs not meet the corroded,affecting the clean room2228floor requirementsrequirementsenvironment洁净室微生物滋生，影响洁净室环境，材质不符合要求进而影响产品质量用于洁净室内排水，隔绝空The materialdoes notmeet theClean roommicrobial breeding,affect2228气防止下水道中空气反流requirementsthe clean room environment,and then入洁净室地漏affect the quality ofproducts9It isused for clean roomFloordrain地面积水，滋生微生物，影响洁净环境drainage toisolate airandWater accumulationon theground,preventairfromsewerirom水封能力不住breeding microorganisms,and affecting2228flowing backinto clean room Insufficient water scalingcapacitythe cleanenvironment洁净室风险评估Risk Assessmentof CleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010117/33功能/关键部件风险优序号说明/任务失效事件最差情况影响Functional/key S P D先性NO.Description/Tasks Failure events Worst-case impactcomponentsRPN材质不符合要求影响洁净室环境The materialdoes notmeet the32212用于密封洁净室内缝隙Affect theclean roomenvironmentrequirements10密封Seal Usedfbr sealingcracksin引起污染或交叉污染clean rooms密封破损Cause contaminationor cross32212Seal thedamage contamination过滤器选型不满足Filterselectionisnotsatisfied过滤器过滤影响洁净室环境效率不满足要求32212Affects theclean roomenvironmentFilter efficiency does notmeet therequirements用于洁净送风过滤净化，保过滤器过滤效率不满足要求过滤效率不能满足要求，影响洁净室证房间满足净化要求Used Filterefficiency does notmeet the环境高效过滤器for cleanairfiltrationand requirements近滤器在生产或安装中被11Filtration efficiencycan notmeet the32212High efficiencyfilter purification,to ensurethatthe损坏requirements,affecting theclean roomroommeetstherequirementsThe filter is damaged during production orenvironmentof purificationinstallation漏风严重，空气未经过高效过滤进入过滤器在生产或安装中被损坏洁净房间影响环境The filteris damagedduringproductionor32212Air leakage is serious,the airis notinstallation严密性不足filtered into theclean room,affecting theLack of rigorenvironment材质不符合要求材质脱落腐蚀，影响洁净室环境The保证房间满足洁净度，压差The materialdoes notmeet thematerial fallsoff andcoirodes,affecting3126及自净的设计要求requirementstheclean roomenvironment送、回、排风口影响房间的正常空气循环，无法保证Ensure thatthe roommeets12Send,return,exhaust airthedesign requirementsof洁净环境outlet安装位置和大小错误cleanliness,differential Affects the normalair circulationof the32212Incorrect installationlocation andsizepressure and self-cleaning.room andcannot guaranteea cleanenvironment文件编号/Code.版本号/Version页码/PageRA-CR-010118/33功能/关键部件风险优序号说明/任务失效事件最差情况影响Functional/key S P D先性NO.Description/Tasks Failure events Worst-case impactcomponentsRPN材质不符合要求The materialdoes notmeet the材质脱落腐蚀，堵塞过滤器Material2228为洁净室送、回、排风需要风管requirements peelingcorrosion,clogging filter13Forclean roomtosend,Duct风管泄漏，洁净室送风量不足return,exhaust airneeds风管安装不符合Air ductleakage,clean roomair supply2228Air duct installation does not conformisinsufficient材质不符合要求用于避免结露或热损耗的产生热损耗The materialdoes notmeet the2228风管保温风险Heat lossgeneration14requirementsDuct insulationTo avoidthe riskof安装不符合导致结露滴水condensationorheat loss2228Installation nonconformityIt causesdew todrip材质脱落腐蚀，无法实现风量的稳定风阀，包括定风量调节材质不符合要求及调节功能阀、变风量调节阀和手The materialdocs notmeet theMaterial falloff corrosion,unable to2228动调节阀requirements achievethe stabilityand regulationof air用于调节风量The airvalve comprisesvolumefunction15Usedforregulating airaconstant airvolume无法正常调节风量以实现房间的正常volumeregulating valve,a风量平衡variable airvolume安装位置错误2228The airvolume cannotbe adjustedregulatingvalve anda Incorrect installation locationproperlyto achievethe normalairmanual regulatingvalvevolume balanceof theroom材质不符合要求材质脱落腐蚀，影响洁净室环境TheThe materialdoes notmeet thematerialfallsoffandcoirodes,affecting32212requirementsthecleanroomenvironment高效过滤器静压箱用于洁净送风及送风均匀漏风严重，空气未经过高效过滤进入16Plenum chamberfor Usedforcleanair supplyand洁净房间影响环境high efficiencyfilter uniformair supply严密性不足Lack ofrigor Airleakageisserious,the airis not32212filtered intothecleanroom,affecting theenvironment功能Function文件编号/Code.版本号/Version页码/PageRA-CR-010119/33功能/关键部件风险优序号说明/任务失效事件最差情况影响Functional/key sP D先性NO.Description/Tasks Failure events Worst-case impactcomponentsRPN影响洁净室生产环境，进而影响产品质量及人员舒适性温湿度控制洁净室温湿度洁净室温湿度超标Affects thecleanroomproduction17Temperature andControl cleanroom Clean room temperature andhumidity32212environment,and thenaffects thehumiditytemperatureandhumidity exceedstandardproduct qualityAffectclean roomproductionenvironment,and thenaffectproduct qualityand personnelcomfort影响洁净室气流流向，引起污染或交控制洁净室压差洁净室压差不符合叉污染压差18Control thedifferential Pressure difference in cleanroom does notAffectstheflow directionof theclean32212Differential pressurepressurein thecleanroommeet room,causing contaminationor crosscontamination控制洁净室的自净能力换气次数不符合影响洁净室的自净能力19换气次数Control theself-cleaning The frequency of ventilation isnot Affectstheself-purificationabilityofthe32212Airchangescapacityof thecleanroom consistentcleanroom悬浮粒子、微生物沉控制洁净室洁净度和微生降菌、浮游菌、物环境影响洁净室环境，从而影响产品质量表面微生物洁净室设计不满足20Controlcleanroom Affectsthecleanroomenvironment,32212Suspended particles,Clean roomdesign isnot satisfiedcleanlinessand microbialthereby affectingproduct qualitymicroorganismssettlingenvironmentbacteria,plankton,surface microorganisms保护操作人员听力安全，保不满足EHS要求证生产过程中的正常沟通洁净室噪音超标影响人员正常操作21噪音Noise32212To protectthe hearingsafetyExcessive noisein clean rooms Affecting the normal operation ofofoperators andensure thepersonnelEHSrequirements arenot metnormalcommunicationduring production目录Index目的

8.2Critical component/function riskassessment andcontrolmatrix15结论

1.Propose本文件将概括基于产品要求的潜在风险并采用系统化的分析或工具提供风险管理措施，同时将作为定义后续确认活动内容的依据This documentwill outlinepotential risksbased on product requirementsand providerisk managementmeasures usingasystematic analysisor tool.It willalso serveas abasis fordefining thecontent ofsubsequent validationactivities.范围

2.Scope本次风险评估的范围适用于的套空调系统，空调系统包括空调机组、高效过滤器、洁净室等本次验证计划的18范围为洁净室区域及其对应的空调系统The scopeof thisriskassessmentis applicabletothe18sets ofairconditioning systems.The airconditioning systemincludes airconditioningunits,high-efficiency filters,cleanrooms,etc.The scopeof thisvalidation planis thecleanroomarea anditscorresponding air-conditioningsystem.空调系统和洁净室的对应关系如下表The correspondingrelationship betweentheairconditioningsystem and thecleanroomis shownin thetablebelow:空调系统编号洁净室区域洁净级别HVAC NO.CleanRoomArea CleanLevel服务于一层灌装间等区域AHU-101CServing areassuch asfilling room on the first floor服务于一层层析间等区域2AHU-102CServing areassuch aschromatography room2on thefirst floor服务于一层缓冲液配制间等区域AHU-103cServing areassuch asbuffer preparation room on thefirst floor服务于一层层析间等区域1AHU-104cServing areassuch aschromatography room1on thefirstfloor服务于二层发酵间等区域1AHU-201DServing areassuch asfermentation room1on the second floor服务于二层发酵间等区域2AHU-202DServing areassuch asfermentation room2on thesecond floor服务于二层培养基准备间等区域AHU-203Serving areassuch asculture mediumpreparationroom2on thesecond Dfloor服务于三层细胞间等区域AHU-301DServing areassuch ascell room2on thethird floor服务于四层上游等区域1AHU-401DServing areassuch asupstream1on the fourth floor服务于四层下游等区域1AHU-402CServing areassuch asdownstream1on thefourth floor服务于四层上游等区域2AHU-403DServing areassuch asupstream2on thefourth floor服务于四层下游等区域2AHU-404CServing areassuch asdownstream2on thefourth floor服务于四层上游等区域3AHU-405DServing areassuch asupstream3on thefourth floor服务于四层下游等区域3AHU-406CServing areassuch asdownstream3on thefourth floor服务于四层上游等区域4AHU-407DServing areassuch asupstream4on thefourth floor洁净室风险评估Risk Assessmentof CleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010130/33功能/关键部件风险优风险优先序号Functional/kev失效事件先性建议采取措施SPD性RPNcomponentsNO.FailureeventsRPNSuggestmeasurestobe takenmicroorganismssettlingbacteria,plankton,surface Thedetectabilityoffailureeventscanbeimproved bymicroorganismstestingthe suspended particlesin cleanroom duringOQstageandthesuspendedparticles andmicroorganismssedimentation bacteria,planktonbacteria andsurface microorganismsin cleanroomduring PQstage通过建立so,定期对洁净室进行清洁消毒降低失效事件发生的可能性ReducethepossibilityoffailureeventsbyestablishingSops toclean anddisinfect cleanrooms regularly通过建立环境监测规程针对悬浮粒子、微生物进行定期测试降低失效事件发生的可能性并提高其可检测性Reducethepossibilityoffailureeventsandimprovetheirdetectabilitybyestablishing environmentalMonitoringprocedures andconducting regular testsfor suspendedparticles andmicroorganisms通过在OQ阶段进行洁净室噪音测试提高失效事发生的可检测性Improvethedetectabilityoffailureeventsbyconducting cleanroom noisetesting duringtheOQ洁净室噪音超标phase21噪音Noise123113Excessive noiseincleanrooms通过编制洁净室SOP针对噪音进行定期测试降低失效事件发生的可能性并提高其可检测性Reducethepossibilityoffailureeventandimproveitsdetectability bypreparing cleanroomSOPto conductregulartest fornoise通过OQ阶段进行照度测试提高失效事发生的可照度洁净室照度不足2212检测性3113Illumination Insufficientlightinclean roomImprovethedetectabilityoffailureeventsby文件编号/Code.版本号/Version页码/PageRA-CR-010131/33功能/关键部件风险优风险优先序号Functional/kev失效事件先性建议采取措施SPD性RPNcomponentsNO.FailureeventsRPNSuggestmeasurestobe takenconductingcleanroomilluminaton testingduring theOQphase通过编制洁净室SOP针对照度进行定期检测降低失效事件发生的可能性并提高其可检测性Thepossibilityoffailureeventscanbereducedandthedetectabilitycan beimprovedbypreparing cleanroomSOPto conductregulartestfor illumination洁净室风险评估Risk Assessmentof CleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010132/

339.结论Conclusion经上述关键性评估后确定22项风险优先性大于等于6的功能和关键部件，通过合理的建议和重新评估后风险优先性已全部小于6After theabove criticalityassessment,22functions andkey componentswith ariskprioritygreater thanor equalto6were identified.After reasonablerecommendations andreassessment,the riskpriority hasall beenless than

6.风险评估结论如下The Risk Assessment conclusiondescribed asbelow:质量风险管理已被适当的实施；-Quality riskmanagement hasbeen properlyimplemented;已有适当方法控制风险；-Appropriate methodsarc inplace to control risks;乘余风险是可接受的-Residual riskis acceptable.应注意，如果详细设计发生了变更，必须重新按照风险评估的方法对系统、功能和部件进行关键性评估It shouldbe notedthat ifthe detaileddesign changes,critical evaluationsof systems,functions and components mustbe redonein accordancewith therisk assessmentmethodology洁净室风险评估RiskAssessmentof CleanRoom文件编号/Code.版本号/Version页码/PageRA-CR-010133/

3310.修订历史Revision History版本号修订内容/修订原因生效日期Version NO.Revision Content/Revision ReasonsAvailability Date新建文件见签批页批准日期01New documentsSee approvaldate on the signatureand approvalpage空调系统编号洁净室区域洁净级别HVAC NO.CleanRoomArea CleanLevel服务于四层下游等区域4AHU-408CServing areassuch asdownstream4on thefourth floor服务于四层灌装间等区域AHU-409CServing areassuch asfilling roomon thefourth floor服务于四层配液间等区域AHU-410cServing areassuch asliquid dispensingroomon thefourthfloor职责

3.Responsibilities（供应商）安装职责

3.1Responsibilities风险评估报告的编写Preparation oftheriskassessment report..提供为报告编写所需要的资料Provide theinformation requiredto preparethis report.（业主）职责

3.2Responsibilities报告的审核和批准Review andapproval ofreports参考文件及规范

4.Reference andRegulation文件/规范编号编号文件/规范名称版本Document/RegulationNo.Document/Regulation NameVersionNumber文件/Document用户需求说明GMP-URS-0511User RequirementsSpecification forCleanRoomGMP-URS-051规范/Regulation中国版GMP20102China GMP2010version医药工业洁净厂房设计规范3Standard fordesign ofpharmaceutical industrycleanroom.质量风险管理4Quality RiskManagement基于风险分析的药品生产5Risk-Based Manufactureof PharmaceuticalProducts.基于风险分析的调试和确认6Applied RiskManagement forCommissioning andQualification.风险管理风险评估技术7Risk management-riskassessmenttechniques基于科学和风险的设施、系统和设备的交付ISPE8ISPE Scienceand Risk-Based Approachfor theDelivery ofFacilities,Systems,and Equipment卷无菌生产设施第版ISPE339ISPE Volume3Sterile ProductManufacturing FacilitiesThird Edition基准指南卷调试与确认第一版ISPE510ISPE Baselineguide vol5:Commissioningqualification Firstedition洁净室及相关受控环境ISO14644-311cleanroomand associatedcontrolled environmentsISO14644-3术语和缩略语

5.Abbreviations缩写描述Abbreviations Describe验证主计划VMPValidation MasterPlan风险评估RARisk Assessment设计确认DQDesign Qualification环境健康安全EHSEnvironment HealthSafety标准操作规程SOPStandard OperatingProcedure用户需求说明URSUser RequirementsSpecification药品生产质量管理规范GMPGood ManufacturingPractice安装确认IQInstallation Qualification操作确认OQOperational Qualification中国药典ChpChinese Pharmacopoeia系统描述

6.System Description根据使用功能的不同，分成相应的三个控制区域，三个区域的净化级别分别为核心生产区为1-2FGMP GMP的生产车间，上游为级，其中接种间为级，下游为级洁净室，辅助功能区为级；其中组合式空D CC CNC调机组为服务于二层上游级净化区域，服务于一层下游级净化区域JK-201〜203D JK-101〜104CSystem description:The53#building ofthe universitypark isdivided intothree con-esponding controlareas accordingtothedifferentfunctions used,andtheclean levelsofthethree areasare:1-2F GMPcore productionarea isGMPproduction workshop.Upstream isD level.Inoculation roomis Clevel.Downstream isC cleanroom.Auxiliaryfunction areais CNClevel;Among them,the combinedairconditioningunit isJK-201〜203serving theupstreamD-level cleanarea ofthesecondfloor,and JK-101〜104serving thedownstream C-level purificationarea ofthe firstfloor.的实验室，其中细胞间为级区域空调系统，其余房间为为区域3F QC/AD/PD3002D JK-301CNCQC/AD/PD laboratoryon3F,where3002cells areintheclass Darea JK-301airconditioningsystemandtheremaining roomsare CNCareas.的生产车间，上游为级，下游为级洁净室，罐装间为级洁净室其中组合式空调机组为、4F GMPrD CC JK-

401、、服务于四层上游级净化区域，、、服务于四层下游JK-403JK-405JK-407D JK-402JK-404JK-

406.JK-408C级净化区域，服务于层罐装车间净化区域JK-4094The GMProproduction workshoponthe4F isClass Dupstream,Class Ccleanroomdownstream,and ClassC cleanroominthefilling room.Among them,the combinedairconditioningunits areJK-401,JK-403,JK-405and JK-407serve thefour-layer upstreamD-level purificationarea,JK-402,JK-404,JK-406,JK-408serve thefour-layerdownstream C-level purificationarea,and JK-409serves thefour-layer canningworkshop purificationarea.传递窗配置不锈钢腔体，风机，照明灯，杀菌灯，液槽高效，不锈钢控制面板，出风面不锈钢孔板H14Transfer windowis equippedwith stainless steel cavity,fan,lamp,germicidal lamp,H14liquid tankhigh efficiency,stainless steelcontrol panel,stainlesssteeloutlet surfaceorifice plate.评估方法

7.Assessment methods功能/部件关键性的确认

7.1Critical confirmationof function/component根据功能和部件对产品质量的影响来评估其关键程度GMPEvaluate theGMP criticaldegree accordingtothe function andcomponents impact onproduct quality.功能和部件的影响评估以产品的个质量参数为基础功效、特性、安全、纯度、质量GMP5The GMPimpact assessmentof functionsandcomponentsis based onthefive qualityparameters ofthe productefficacy,characteristics,safety,purity,quality.对于每一项会对产品质量产生影响的功能、所有提供该功能的设备、部件或仪表都归类为关键和非关键两种，这种归类将根据下列问题进行For eachfunction thathas animpact onthequalityofthe product,and forall equipment,components orinstruments thatprovidethefunction,the classificationwill becritical ornon-critical basedonthefollowing questions:.部件是否用于证明符合所注册工艺的规定？AAre components used todemonstrate compliancewith therequirementsofthe registeredprocess功能/部件是否用于控制一个关键工艺参数？

8.Are functions/components usedtocontrola keyprocess parameter功能/部件的正常操作或控制对产品质量或功效具有直接的影响？C.Does thenormaloperationor controlof functions/components have a directimpactonproduct qualityor efficacy从功能/部件获取的信息被记录为批记录、批放行数据或其它相关文件的一部分？D.GMPIs informationobtained fromfunctions/components recordedas partof batchrecords,batch releasedata orotherGMP-related documents部件是否与产品、产品成分或产品内包材直接接触？E.Is thecomponent indirect contactwith theproduct,product ingredientsor productinner packingmaterial功能/部件是否用于获得，维护，测量或控制可以影响产品质量的关键工艺参数，而对控制系统性能无独立F.的验证？Are functions/components usedto obtain,maintain,measure orcontrol keyprocess parametersthat canaffect productqualitywithout independentveri1ication ofthe performanceofthecontrol system功能/部件是否用于创建或保持某种系统的关键状态？G.Are features/componentsusedto createor maintaina criticalstate ofa system七个问题中只要有一个问题的答案是“Yes”，就将该功能/部件归类为关键的功能/部件If theanswer toone ofthe sevenquestions isYes，the feature/part isclassified asa criticalfeature/part.“Y”是“N否“N/A”不适用，“Yes:No“N/A”Not applicable关键性部件风险评估

7.2Risk assessmentof criticalcomponents风险确认可能影响产品质量、产量、工艺操作或数据完整性的风险；Risk identification:risks thatmay affectproductquality,yield,process operationor dataintegrity;风险判定包括评估先前确认风险的后果，其建立在严重程度、可能性及可检测性上；Risk determination:includes assessingthe consequencesof previouslyidentified risksbasedonseverity,likelihood anddetectability;严重性SSeverity对失效可能造成的影响进行描述即失效发生的严重性Describe thepossible impactofthefailure i.e.the severityofthefailure.严重性描述Severity SDescribe预期具有较小的负面影响所导致可预期的危害具有非常微小即为短期的有害影响低Low1Small negativeeffects are expected.The resultingpredictable harmhas verysmall,orshort-term,harmful effects.预期具有中等的影响可预期的影响即为中度的有害影响中Medium2Moderate effects areexpected.The expectedeffectsaremoderately harmful.预期将具有非常显著的负面影响可预期的影响具有显著的长期影响和/或可能是灾难性的短期影响高High3It isexpected tohaveavery significantnegative impact.Foreseeable effectshave significantlong-term effectsand/or potentiallycatastrophic short-term effects.可能性Probability P描述失效发生的可能性依据失效来源的描述Describe thelikelihoodofa failureoccurring basedonthedescription ofthe sourceofthefailure.可能性描述Probability PDescribe产品生命周期内不可能发生低Low1Not likelyto occurduringtheproduct life cycle.产品生命周期内可能会发生中Medium2May occurduringtheproduct lifecycle.产品生命周期内将会发生几次高High3High3:This willhappen severaltimes duringtheproductlifecycle.可检测性Sex canbe detectedD描述故障的可检测性Describe thedetectabilityofa fault.可检测性Sex canbe描述Describedetected D认为缺陷状况的检测是不太可能的例如，在每发生次检测到次以下31低Low3Defect statusisconsideredunlikely tobe detectedforexample,lessthan1out ofevery3occurrentions.。