中英文版APIC原料药厂GMP审计表XXX

中英文版APIC原料药厂GMP审计表XXXQ7条款英文内容中文内容11Introduction介绍21.3Scope范畴3　HasthecompanydesignatedthepointatwhichtheproductionoftheAPIbegins?是否决定了API生产起点?4　Canarationalebeprovidedforthisdecision?决定的理由？5　Hasthedecisionbeendiscussedwiththerespectiveauthority?是否与有关药政部门讨论过该决定6　Arethequalitycriticalstepsidentified?是否确认了关键质量步骤72QualityManagement质量治理82.1Principles原那么92.11ACertifiedQualityManagementSystem(e.g.ISO9001)isimplemented?(ifyes,seechapter20)质量治理系统是否通过认证〔例如ISO9001〕?(已通过者参见第20章)102.12Isthereaqualitypolicy?有无质量政策？11　Howisitbroughttotheattentionoftheemployees?如何在职员中贯彻质量政策？12　IsthereaQualityManualorequivalentdocumentationthatdescribesindetailhowtheQualitySystemisimplemented?是否有质量手册一类的文件来详细MATCH_ word word文档格式规范word作业纸小票打印word模板word简历模板免费word简历 _1714288876538_0如何贯彻运作质量体系？13　HowdoesManagementrevieweffectivenessofqualitysystem治理层如何了解质量体系的成效142.13IstheQualityUnit(QA/QC)independentofproduction?QA/QC是否独立于生产部门？152.14Isthereanauthorizedperson(s)forthereleaseofIMandAPIs?是否由质量授权人放行IM和API?16　Whoistheperson(s)?谁是质量授权人？172.16Arealldeviationsdocumentedandexplained?是否所有偏差都有记录和说明?18　Arecriticaldeviationsinvestigatedinatimelymanner?严峻偏差是否及时进行调查？19　Isthereawrittenprocedureforhandlinginvestigations(6.53)?是否有书面的调查程序？20　Averagedaysforcompletion?平均要调查几天？212.17HowisitensuredthatmaterialsarenotreleasedorusedbeforecompletionofevaluationbytheQU?如何保证未经质量部门〔QU〕完成评估的物料可不能放行或使用?22　IfnotdonebyQU:Isanappropriatesysteminplace?如何不是由质量部门〔QU〕负责此事。有否其它相应机构？232.18HowismanagementnotifiedofseriousGMPdeficiencies,qualityrelatedcomplaintsand/orproductdefects?显现GMP偏离，质量投诉和产品缺陷，如何通知治理层？24　Averagetimeneededforinformation?这种通知平均需要多少时刻？252.2ResponsibilitiesoftheQUQU职责262.21ArethereproceduresthatensurethatQUreviewsandapprovesallqualityrelateddocuments?是否制定了确保QU审核批准与质量有关的所有文件？272.22Non-transferableresponsibilitiesofQU:QU直截了当担负的责任：28　release/rejectionofAPIsandIM(tobesold)IM和API的放行/拒绝29　establishsystemtorelease/rejectmaterialsandlabels建立物料和标签放行/拒绝的体系30　reviewofcriticalprocessstepsbatchrecords审核批记录的关键工艺步骤31　ensurecriticaldeviationsareinvestigated确保严峻的偏离得到调查32　approvingspecificationsandmasterinstructions批准质量 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 和工艺规程33　approvingallqualityrelateddocuments批准所有的有关质量的文件34　ensuringconductionofinternalaudits确保进行自检35　approvingcontractmanufacturers批准合同制造商36　approvingchangeswithqualityimpact批准涉及质量的变更37　approvingvalidationdocuments批注验证文件38　ensurecomplaintsareresolved确保投诉得到处理39　ensuringcalibrationsystemisfunctioningaccordingtoprocedureexecuted确保校验工作按照既定程序进行40　ensuringthatstabilitydataisgeneratedandreviewed确保稳固性数据得以记录和审核41　performingproductqualityreviews进行产品质量核查422.3ResponsibilitiesforProductionActivities生产活动职责43　procedureforpreparing,reviewingandapprovinginstructions起草，审核批准指令的程序44　reviewingbatchproductionrecords审核批生产记录45　ensurealldeviationsandinvestigationsarehandled确保对所有偏差进行调查处理46　cleaningoffacilities设施得以清洗47　calibrationsperformed校验得以进行48　validationdocumentsgenerated建立验证文件49　evaluationofproposedchanges评估变更申请50　ensurethatfacilitiesandequipmentarequalified确保设施仪器得以确认512.4InternalAudits自检52　Areregularauditsperformed?是否定期自检？53　Isthereanauditschedule?有无自检打算？54　Istheschedulefollowed?自检是否按打算进行？552.41Areauditfindingsandcorrectiveactionsdocumented?自检和改正行动是否有文件记录？56　Proceduretonotifymanagementofauditfindings?向治理层通报自检结果的程序?57　Arecorrectiveactionscompletedwithinagreedtime(aretheresignificantdelays?)是否按期改正〔有无明显拖延？〕582.5ProductQualityReview产品质量审查592.50AreregularProductQualityReviewsconductedforallproducts?是否对所有产品进行了定期质量审查？60　Frequency(dedicated,campaign)?审查频率〔常规进行，偶然?〕61　Content(atleast):审查至少包括以下内容：62　reviewofcriticalIPCandAPItestresults审查关键中间体和API化验结果63　reviewofallbatchesfailed审查所有的不合格批次64　reviewofallcriticaldeviations审查所有的严峻偏差65　reviewofprocesschangesandimpactonquality审查工艺变更及其对质量的阻碍66　reviewofchangestoanalyticalmethods审查分析 方法 快递客服问题件处理详细方法山木方法pdf计算方法pdf华与华方法下载八字理论方法下载 的变更67　reviewofresultsofongoingstabilityprogrammes审查正在进行的稳固性试验结果68　reviewofreturns,complaints,recalls审查退货，投诉，召回69　reviewofadequacyofcorrectiveactionsdefinedinpreviousreview审查过去的改正活动是否恰当702.51Evaluationandassessmentforneedofadditionalcorrectiveactionstoaddressrecurringissuesand/orneedforprocessorcleaningrevalidation评估关于反复显现得问 题 快递公司问题件快递公司问题件货款处理关于圆的周长面积重点题型关于解方程组的题及答案关于南海问题 是否需要加大改正力度713Personnel人员723.1PersonnelQualifications人员确认733.10Adequatenumberofpersonnel?人数是否足够?74　Qualificationofpersonnelsufficientatdifferentlevels?对各级人员的确认是否恰当？753.11AreresponsibilitiesofallpersonnelengagedinmanufactureinAPIsinwritingavailable?从事API制造活动的人员是否有书面的岗位责任书？76　Areresponsibilitiesperiodicallyreviewedtoensuretheyarecurrent?是否对岗位责任书定期审查以确保是现行版？773.12Isregulartrainingconducted?是否进行定期培训？78　Arerecordsoftrainingmaintained?是否储存了培训记录？79　Iseffectivenessoftrainingevaluated?是否对培训成效进行评估？80　How?如何评估？813.2PersonnelHygiene职员卫生823.21Dopersonnelwearcleanclothingsuitableforactivity?职员是否穿着洁净的适于工作的服装？83　Additionalprotectiveapparelwherenecessary(e.g.FinalProductPackingRooms)?在需要的岗位是否外加爱护服？〔例如，最终产品包装室〕843.22HowisitensuredthatpersonnelhavenodirectcontactwithIMandAPIs?如何确保人员没有直截了当接触物料和API?853.23Howisitensuredthatnosmoking,drinking,chewingandstorageoffoodtakesplace?如何确保人员没有在车间抽烟，吃喝，储存食物?863.24Howarepersonnelwithinfectiousdiseasesoropenlesionsidentified?如何识别职员有传染性疾病和开放性伤口？87　Isthereaprocedureinplacethatthesepersonshavenoproductcontact?现场是否有程序确定这些职员不得接触产品?883.3Consultants咨询89　AreconsultantsusedtoadviseonanyGMPrelatedactivities?是否聘请顾问指导有关GMP的活动？90　Isthereanassessmentofconsultant’seducation,trainingandexperience?是否对顾问的教育背景，同意的培训和体会进行了评估？914BuildingsandFacilities建筑和设施924.1DesignandConstruction设计和建设93　Cancleaningandmaintenancebeeasilyperformedbasedondesignofequipmentandlayoutoffacility?Haveproductionandwarehousefacilitiesbeendesignedtopreventcontaminationorcrosscontamination?设施平面布置和设备的设计是否利于清洗和爱护？94　Ifnot,howiscontaminationprevented?假如不能，那如何防止污染？954.11Isthereadequatespaceforplacementofequipmenttopreventmix-uporcontamination?设备的安放空间是否足够防止混淆和污染？964.12Outdoorequipmentraisesconcernsforcontamination?室外安置的设备如何幸免污染?974.13Doesflowofmaterialsandpersonnelraiseconcernsforcontamination?物流和人流是否引致污染？984.14Definedareasorcontrolsystemsinplaceforthefollowingactivities:以下活动是否制定专门区域和配置操纵系统：99　receipt,identification,samplingofincomingmaterials到货的接收，识别和取样100　quarantinebeforerelease/reject放行/拒绝之前的待验101　SamplingofintermediatesorAPI’s中间体或API的取样102　holdingofrejectedmaterialsbeforefurtherdisposition?不合格品进一步处理前的存放103　Packagingandlabelingoperations?包装和贴签操作1044.15Washingfacilitiesandtoiletsavailableforpersonnel?职员卫生间1054.16Laboratoryareasseparatedfromproduction?化验室和生产区是否分开？1064.2Utilities公用设施1074.20Allutilitiesthatcouldimpactonproductqualityareidentifiedandqualified?对可能阻碍产品质量的公用设施是否进行了识别和确认？108　Aretheutilitiesmonitoredandactionstakenwhenalertlimitsareexceeded?公用实施是否有监控，以便报警采取措施？1094.21Adequateventilation,airfiltrationandexhaustsystemsinplace?现场是否有足够的通风，过滤和排风系统?110　Arethesesystemsdesignedandoperatedtopreventcontamination?这些系统的设计和运行是否可防止污染？1114.22Controlofre-circulatedairsufficienttoavoidcontamination?对循环风是否采取了足够的操纵幸免污染？1124.23Permanentlyinstalledpipeworkappropriatelyidentified?固定管道系统是否易于识别？113　Ispipeworkmaintainedandlocatedinsuchawayastopreventcontamination?管道系统的爱护和位置是否可防止污染？1144.24Aredrainsdesignedtopreventback-siphonageormicrobiologicalcontaminationinareaswhereproductisexposed?生产区地漏的设计能否防止反流或微生物污染？1154.3Water水1164.30Waterdemonstratedtobesuitableforintendeduse?是否能证实水质符合相应的用水标准？1174.31IsProcesswatermeetingdrinkingwaterqualityasaminimumstandard?工艺用水的最低标准是达到饮用水标准？118　Isadditionalwatertreatmentsysteminplace?现场有无附加的水处理系统？119　Isqualityofallgradesofprocesswatermonitoredatpointsofuseforphysical/chemicalattributes,totalmicrobialcounts,objectionableorganisms?是否对各级工艺用水的用水点进行物理/化学指标监测？120　Areactionstakenwhenlimitsareexceeded?超标时采取行动吗？1214.32Tighterspecificationsneededtoensurequality?为保证质量，是否设定更严格的内控指标？122　Whatarethespecifications?这些内控指标是什么?1234.33Validationoftreatmentof(higher)watertreatment?是否验证水处理的处理1244.34Ifclaimsaremadeforsterileorparenteraluse:无菌或注射级原料：125　Monitormicrobialcounts,objectionablemicroorganismsandendotoxins监测微生物计数，不良微生物和内毒素1264.4Containment污染1274.40Forhighlysensitizingmaterialsarededicatedproductionareas(facilities,airsystems,equipment)inuse?高敏物料是否有专用生产区〔设施，空调系统〕1284.41Dedicatedproductionareaforhighpharmacologicalactivity高活性药物专用生产区1294.42Aretheremeasurestopreventcross-contaminationfrompersonnel,materialsetc.forexamplemovingfromoneproductionareatoanother?是否建立防止人员物料交叉污染的措施？〔例如，从一个生产区转移到另外区域〕1304.43Productionofhighlytoxic,non-pharmaceuticalproducts,forexamplepesticidesexcludedfrompharmaceuticalproductionfacilities?制药车间是否从事高毒非药物制品的生产〔例如，杀虫剂〕？1314.5Lighting照明132　Adequatelightingfore.g.cleaningandmaintenance充足的照明〔例如，清洗和爱护〕1334.6SewageandRefuse污水和垃圾1344.60Sewagetoberemovedtimely污水及时排除1354.7SanitationandMaintenance清洁和爱护1364.70Buildingstobekeptproperlymaintained,repairedandcleaned建筑物得到适当的修理和清洁1374.71Writtenproceduresforcleaningforequipmentandfacilitiesinplace现场有书面的设备和设施清洁程序1384.72Proceduresforpestcontrolinplace?现场有防虫措施1395ProcessEquipment工艺设备1405.1DesignandConstruction设计建筑1415.10Equipmentsuitablylocated,easytocleanandmaintain?设备安装易于清洁和爱护？1425.11Equipmentsurfacesdonotalterproductquality设备表面可不能阻碍产品质量1435.12Equipmentonlyusedwithinthequalifiedoperationrange?设备只在确认的运行范畴使用1445.13Majorequipmentandpermanentlyinstalledpipeworkidentified要紧设备和固定管线易于识别1455.14LubricantsnotincontactwithIMandAPIs?Otherwisefoodgradelubricantsused?润滑剂是否接触物料和API？否那么使用食品级润滑剂？1465.15Precautions(measures)takenwhereequipmentisopenedtopreventcontamination?Forexampleadditionofseedsorsampling设备敞口时们是否采取防污染措施？〔例如，加晶种和取样〕1475.16Arecurrentengineeringdrawingsavailableforequipment,installationsandutilitysystems?设备，安装和公用工程的技术图纸是否为最新版？1485.2EquipmentMaintenanceandCleaning设备修理和清洁1495.20Preventivemaintenanceprogrammeinplace?是否采取了预防性修理打算？150　Schedulefollowed?是否按打算进行？1515.21Writtenproceduresforthecleaningofequipmentinplace?有无书面的设备清洁程序？152　Dotheproceduresgivesufficientdetailtoenableoperatorstocleaneachtypeofequipmentinaneffectiveandreproduciblemanner?程序是否详尽，使得操作人员以有效的不走样的方式清洁每一种设备？1535.22Areequipmentandutensils,suchassamplingdevicescleaned,storedandwhereappropriatesanitizedorsterilizedtopreventcontaminationorcarry-overofamaterialthatwouldaffectthequalityoftheIMorAPI?仪器和工具，例如取样工具是否清洗，存放并采取适当消毒灭菌措施，从而防止传播可能阻碍IM和API质量的物质？1545.23Continuousproductionordedicatedproductionfacilities:isequipment/facilitycleanedatappropriateintervalstopreventbuild-uporcarryoverofcontaminantsforexampledegradantsorobjectionablelevelsofmicro-organisms?连续生产或专用生产设施：设备/设施是否定期清洗防止积料或传播污染物，例如，降解物或过多的微生物？155　Isthecleaningfrequencyjustifiedanddocumented?清洗频率是否合适并有文件规定？1565.24Isequipmentcleanedbetweenproductionofdifferentproducts?不同品种生产之间设备是否清洗？1575.25Formulti-purposeequipmentistheMaximumAcceptableCarryOverandotherAcceptancecriteriaforresiduesjustifiedanddetermined?关于多用途设备，是否规定了可同意的最大残留水平和其他指标，规定是否合理？158　Arethecleaningproceduresvalidated?是否验证清洗程序？1595.26Equipmentidentifiedastoitscontentandcleanlinessstatus?设备清洗状态和内容物是否有标识牌？1605.3Calibration校验1615.30InstrumentscriticalforIMand/orAPIqualityarecalibrated?涉及IM和API质量的关键外表是否校验？162　Howiscriticaldefined?关键外表如何确定？163　Writtenprocedureinplace?是否有书面程序？164　Schedulefollowed?是否按照规定进行校验？1655.31Calibrationdonewithstandardsthataretraceabletocertifiedstandards?校验使用的衡器是否可追朔到法定标准？1665.32Recordsofcalibrationmaintained?有关的校验记录？1675.33Calibrationstatusofinstrumentsknown?外表校验状态？168　How(label,electronic)?校验状态是标签式或电子式？1695.34Howisitensuredthatinstrumentsoutofcalibrationarenotused?如何保证未经校验的外表不得使用？1705.35Ifinstrumentshavebeenshownoutofcalibration,aredeviationinvestigationsperformedtodetermineifthisfacthasaninfluenceonthereleaseoftheIM/API?如发觉外表已过校验有效期，是否进行偏差调查来决定是否放行有关的IM和API？1715.4ComputerisedSystems运算机系统1725.40AreGMPrelatedcomputersystemsvalidated?与GMP有关的运算机系统是否验证？1735.41IQ,OQforHard-andSoftwareavailabletodemonstratesuitabilityofcomputerhardware/softwaretoperformtask?软硬件的IQ,OQ是否能证实软硬件能够满足工作需要？1745.42Retrospectivevalidationforexistingsystemsifnotvalidatedattimeofinstallation?假如现存系统安装时没有进行验证，是否进行了回忆性验证？1755.43Whatcontrolsareinplacetopreventunauthorizedaccess?采取何种措施防止非授权进入运算机系统？176　Whatcontrolsareinplacetopreventchangestodata?采取何种措施防止修改数据？177　Whatcontrolsareinplacetopreventomissionsindata?采取何种措施防止数据错漏？178　Isthereanaudittrail/documentsavailablewherechangestodataarerecorded,whomadethechange,whenthechangewasmadeandofthepreviousentry?关于那些数据进行了更换，谁进行的更换，何时进行的，原先输入的什么数据等，有无核查/文件记录？1795.44Writtenproceduresfortheoperationandmaintenanceofcomputerizedsystemsavailable?运算机系统的运行爱护有无书面规定？1805.45Isthemanualentryofcriticaldatacheckedbyadditionalmeans(secondoperatororsystemitself)?人工输入关键数据是否有额外的复核手段〔其他人员或系统自己〕？1815.46Areallqualityrelatedincidentsanddeviationsrelatingtocomputerizedsystemsinvestigatedaccordingtodefinedproceduresinvestigated?运算机系统发生涉及质量的故障和偏差是否按照既定步骤进行调查？1825.47Changestothecomputerizedsystemaremadeaccordingtoadefinedprocedure?是否按照既定步骤进行运算机系统变更？1835.48Howisdataprotectedincasesofsystembreakdowns?系统发生瘫痪时如何爱护数据？184　Back-upsystemprovided?有无备份系统？185　IsRecoveryfromback-upstestedperiodically?是否定期进行从备份复原系统的演练？1866DocumentationandRecords文件和记录1876.1DocumentationSystemandSpecifications文件系统和标准1886.10Isthereawrittenprocedureinplacedescribingpreparation,review,approvalanddistributionofallqualityrelateddocuments?是否有书面规定描述如何起草，审核，批准和分发与质量有关的所有文件？1896.11Howisrevision,supersedingandwithdrawalofdocumentscontrolled?如何操纵文件的修订，替代和撤销？190　Isarevisionhistorymaintained?是否表达了文件修订历史？1916.12Procedureinplaceforretainingallappropriatedocuments?关于各种文件保留有无书面规定？192　Retentionperiodspecified?文件的保留期限？1936.13RetentionperiodforAPIswithexpirydate:1yearafterexpiry(min.)有有效期的API文件：至少保留到有效期以后1年194　RetentionperiodforAPIswithretestdate:3yearsaftercompletedistribution(min.)有复验期的API文件：至少保留到全部分发完成后3年1956.14Arecorrectedentriesindocumentsdatedandsigned?文件改动处是否签上日期和姓名？196　Originalentrystillreadable?原先的数据是否依旧可见？1976.15Aredocumentspromptlyretrievable(copiesorelectronicmeansacceptable)?文件是否能够迅速查找〔印刷版或电子版都能够〕？1986.17Arespecificationsforallmaterials,IMandAPIsestablished?是否建立了所有的IM和API质量标准？1996.18Areelectronicsignaturesauthenticatedandsecure?电子签名是否授权和安全？2006.2EquipmentCleaningandUseRecords仪器清洁和使用记录2016.20Arethererecordsforthemajorequipmentused,cleaningandmaintenanceshowingthefollowing要紧仪器的使用，清洁和爱护记录要包括以下内容：202　date，time日期，时刻203　productandbatchnumberofeachbatch产品和批号204　personwhoperformedcleaning清洁人员姓名205　personwhoperformedmaintenance爱护人员姓名2066.3RecordsofRawMaterials,IM,APILabelingandPackagingMaterials原料，IM,API标签和包装材料的记录2076.30Recordsofeachdeliveryshouldcontain:发货记录应包括：208　nameofmanufacturer/supplier生产商/供应商名称209　identityandquantity标识和数量210　suppliercontroloridentificationnumber供应商操纵或标识码211　numberallocatedonreceipt收货时给予的号码212　dateofreceipt收货日期213　acceptableconditionofreceivedgoodsassessed收货条件是否进行评估214　resultoftestsandconclusionderivedfromthis检验结果和检验结论215　traceofuse使用的踪迹216　reviewoflabelsandpackagingmaterialsshowingconformitywithspecifications审查标签和包材是否符合质量标准217　finaldecisionreleaseorreject放行或拒绝的最后决定权2186.31Aremasterlabelsmaintained?是否储存标签母版？2196.4MasterProductionInstructions生产工艺规程2206.40AreMasterProductionInstructionsforeachIM/API每个IM/API是否都有生产工艺规程？221　prepared起草222　dated日期223　signed签名224　independentlycheckedbyQU由质量部门独立审核2256.41DoMasterProductionInstructionscontainthefollowing:生产工艺规程是否包括以下内容：226　nameofproductincludingdocumentreferencecode产品名称包括其文献编码227　completelistofrawmaterials全部原料清单228　accuratestatementofquantitiesneededorcalculationofquantity准确表达所需的数量或运算方法229　productionlocationandmajorequipmenttobeused生产地点和使用的要紧设备230　detailedproductioninstructionsincludingsequences,rangesofparameters,samplinginstructions,IPC,timelimits,expectedyield详细的工艺规程包括顺序，参数范畴，取样方法，IPC,时刻限度，预期收率231　instructionsforstorage储存方法2326.5BatchProductionRecords批生产记录2336.50AreBatchProductionRecordscheckedbeforeissuanceforcorrectversion?批生产记录发放前是否审查版本是否正确？2346.51Aretherecordsshowinganuniquebatchnumber(notforcontinuousproduction)?批记录是否有唯独的批号〔非连续性生产〕？2356.52Thebatchrecordshouldcontainthefollowing:批记录应包括：236　date(s)andtimes(ifappropriate)日期和时刻〔如适用〕237　identityofmajorequipment验明要紧设备238　identificationofmaterialsused验明所用的物料239　actualresults实际结果240　samplingperformed取样241　signaturesoftheperson(s)performingtheoperation操作者签名242　IPC/laboratorytestresultsIPC/化验室测试结果243　actualyield,ifappropriate实际收率，如适用244　descriptionofpackagingandlabelsused如何包装和所用标签245　deviation/investigation偏差/调查246　resultsofreleasetesting放行化验结果2476.6LaboratoryControlRecords化验室记录2486.60Laboratoryrecordsshouldcontainthefollowing:化验室记录应包括：249　descriptionofsampleincludingname,batchnumberorcode,datewhensamplewastaken,quantity样品名称，批号或编码，取样日期和数量250　referencetotestmethod测试方法标准品251　crossreferencetopreparationofreferencestandards,reagentsand/orstandardsolutions配置对比品，试剂和/或标准液是否进行交叉对比？252　completerecordofallrawdata所有原始数据的记录253　recordofallcalculations所有运算记录254　statementoftestresultiftheycomplywithspecifications测试结果是否达标的结论255　signatureanddateofperson(s)performingthetesting操作人签名和日期256　signatureofsecondpersondemonstratingreviewforaccuracy,completeness确认准确性和完整性的复核人签名2576.61Otherrecordstobemaintained:其它需要储存的记录：258　modificationtotestmethod化验方法的变更259　calibrationoflaboratoryinstruments化验仪器校验260　stabilitytestingperformed稳固性试验261　OOSinvestigationsOOS调查2626.7BatchProductionRecordReview批记录的审查2636.70Isawrittenprocedureforthehandlingofbatch(laboratory)recordreviewavailable?是否建立了批阅批〔化验室〕记录的书面程序？2646.71Arebatch(laboratory)recordsofcriticalstepsreviewedbytheQU?质量部门是否批阅批〔化验室〕记录的关键步骤？265　AretheyreviewedbeforethereleaseoftheAPI?是否在API放行前进行批阅？2666.72Arealldeviations,investigationsandOOSreviewedaspartofthebatchrecordreview?是否批阅批记录所有的偏差，调查和OOS?2676.73IstheQUreleasingallIMthatareshippedoutsidethecontrolofthecompany?当IM发运到不受本厂操纵的外单位,是否由质量部门放行？2687MaterialsManagement物料治理2697.1GeneralControls一样操纵2707.10Arewrittenproceduresavailableforhandlingofreceipt,identification,quarantine,storage,sampling,testing,approvalorrejectionofmaterials?物料的接收，识别，待验，存放，取样，化验，批注或拒绝是否有书面程？2717.11Systemtoevaluatesuppliersofcriticalmaterialsinplace?是否建立关键物料供应商的评估系统？272　Evaluationmustshowthatsuppliercanconsistentlyprovidematerialmeetingspecifications(7.31)平谷必须说明供应商能够连续提供符合质量标准的物料〔7.31〕2737.12Materialspurchasedagainstagreedspecifications?是否采购了不符合质量标准的物料？274　Purchasedfromanapproved(byQU)supplier?是否从质量部门批准的供应商采购？2757.13Ifsupplierisnotthemanufacturer,istheoriginalmanufacturerknown?假如供应商并非制造商，是否知晓原制造厂？2767.14Changeofsource/supplierhandledaccordingtoChangeControlprocedures(chap.13)?是否按照变更程序处理供货源/供应商的变更？2777.2ReceiptandQuarantine收货和待验2787.20Uponreceiptmaterialsvisuallyexaminedfor到货时是否目测以下指标：279　correctlabeling标签正确280　containerdamage包装破旧281　brokenseals密封破裂282　tamperingorcontamination窜改或污染283　Arematerialsheldunderquarantineuntilreleasedforuse?物料在放行使用前是否处于待验状态？284　Howisthisdone?如何进行的？2857.21Incomingmaterialsarereleasedbeforemixedwithexistingstocks?来料是否放行后，才能与存货混合？286　Areproceduresinplacetopreventdischargingmaterialswrongly?是否建立防止误发物料的措施？2877.22Ifdeliveriesaremadeinnon-dedicatedtankerswhichassuranceisprovidedtodemonstratenocontamination(oneormoreofthefollowing):使用非专用储罐发料，采取那些以下措施来证实没有污染：288　certificateofcleaning清洗合格证289　testingfortraceimpurities残留水平化验290