WHOGMP检查报告指南

1WorldHealthOrganization世界卫生组织WHOTechnicalReportSeries,No.908,2023WHO技术报告系列第908号，2023年Annex6附录6GuidanceonGoodManufacturingPractices(GMP):inspectionreportGMP检查报告指南Whenasiteatwhichpharmaceuticalproductsaremanufacturedisinspected,theinspector(s)responsiblemustdrawupareportcontainingtheitemslistedbelow.Whererelevant,theappropriatesectionoftheWHOGMP(Annex4)isindicated.内容，在WHOGMP〔附录4〕局部进展说明Manufacturer生产企业Nameofinspectedmanufacturer.被检查的企业名称Addressofinspectedmanufacturer(includingtelephone,fax,emailand24-hourtelephonenumbers).被检查企业的地址〔包括、、e-mail和24小时号码〕Addressofmanufacturingsiteifdifferentfromthatgivenabove.生产场所的地址〔假设与上述不全都〕Sitenumber(e.g.sitemaster fileornumberallocatedbytheresponsibleauthority).生产场所的注册号〔如：生产场所主文件或当地行政机关安排的号码〕Manufacturinglicencenumber,ifapplicable.生产执照号，假设有Activities.业务Pharmaceuticalproductsmanufactured.所生产的药品Keypersonnel.关键人员Keypersonsmet.会见的关键人员Inspectiondetails检查细节Date(s)ofinspection(s).检查日期Previousinspectiondate.上次检查日期Typeofinspection.检查方式Scopeofinspection.检查范围Theregulatoryauthority.行政机关GMPguidelinesusedforassessingcompliance.用于评估符合性的GMP指南Forforeigninspectionsstatewhether,thenationalregulatoryauthority(NRA)ofthecountrywheretheinspectiontookplacewasinformedandwhetherittookpartintheinspection.否参与检查。Briefreportofinspectionactivitiesundertaken.简要报告检查的过程Samplestakenandresultsobtained.取样及所得结果Assessmentofthesitemasterfile.生产场所主文件评估状况GMP-relatedrecallsfromthemarketofanyproductinthelast2years.最近2年GMP有关的任何产品从市场收回的状况Inspector(s)检查员(a)Name(s)ofinspector(s)andaccompanyingexperts.检查员的姓名和伴随专家Introduction介绍Briefsummaryofthemanufacturingactivities.简要汇总生产状况Othermanufacturingactivitiescarriedoutonthesite(e.g.manufactureofcosmetics,researchanddevelopment).生产场所其他的生产状况(如：扮装品生产，争论和开发)Useofoutsidescientific,analytical,orothertechnicalassistanceinmanufactureandqualitycontrol.使用外部科研、分析或其他在生产和质量把握方面的技术支持Briefdescriptionofthequalitymanagementsystemofthe responsibleformanufacture.Referencecanbemadetoasitemasterfileifoneisavailable.文件的附件供给。Observations观看状况Theobservationsmadeduringtheinspectionthatareconsideredtobenon-compliantwithGMPshouldbelisted.Wherepositiveobservationsareincludedinthereport,cleardistinctionshouldbemadebetween“positive”and“non-compliant”.Non-compliantobservationscanbeclassified,e.g.as“critical”,“major”and“minor”iftheMemberStateconcernedhasdefinedtheseterms.Thedatebywhichcorrectiveactionandcompletionarerequestedinaccordancewiththepolicyofthenationalregulatoryauthorityshouldbegiven.在检查过程中觉察的被认为不符合GMP的状况应排列出来。在报告中也应包括“严峻”、“主要”、“略微”，假设有关成员国有这些定义。整改的日期和依据国家行政机构政策的要求完成整改。Qualityassurance(seeWHOGMP,section1)质量保证〔见WHOGMP,section1)(a)Qualitysystemanddocumentedqualitypolicyofthemanufacturer,e.g.asdescribedinthequalitymanual.质量体系和生产企业文件化的质量政策，如质量手册等Organizationandpersonnel机构和人员(seeWHOGMP,section9)Organizationalchartshowingthearrangementsforqualityassurance,includingproductionandqualitycontrol.说明质量保证机构的组织机构图，包括生产部门和质量把握部门Qualifications,experienceandresponsibilitiesofkeypersonnel.关键人员的资格、阅历和职责Outlineofarrangementsforbasicandin-servicetrainingandmethodofkeepingrecords.根本机构的概述和在职培训和保持记录的方法Healthrequirementsforpersonnelengagedinproduction.参与生产人员的安康要求Personnelhygienerequirements,includingclothing.人员卫生要求包括着装Premises(seeWHOGMP,section12)厂房(见WHOGMP，第12节)Manufacturingareas(design,locationetc.)usede.g.forstorageandmanufacturing(e.g.weighing,production,packaging)andflowofpersonnelandmaterial.〔设计，位置等〕如：储存区和生产区〔如：称量、生产、包装〕和人流、物流。Specialareasforthehandlingofhighlytoxic,hazardousandsensitizingmaterials.处理高毒性、高危急性和高致敏物料的特地区域。Natureofconstructionandfinishes.厂房构造和内外表的性质Systemssuchasdrainage,ventilation,airconditioning,and supplyofsteamandgas.Detaileddescriptionofcriticalareaswithpotentialrisksofcontaminationandcross-contamination.潜在风险的关键区域。Classificationoftheroomsusedforthemanufactureofproducts,includingcleanrooms.用于药品生产房间的级别，包括干净房间Watersystems.水系统Plannedpreventativemaintenanceprogramme.已打算的预防性修理程序Qualificationofpremisesandsystemsasappropriate.厂房和系统确实认Equipment(seeWHOGMP,section13)设备(见WHOGMP，第13节)Design,locationandadaptationofequipmentusedinproductionandcontrollaboratories.生产和把握试验室的设备的设计、定位和选用Plannedpreventativemaintenanceprogrammesforequipmentandrecords.已打算的预防性设备修理程序和记录Qualificationandcalibration,includingrecords.确认和校验，包括记录Materials(seeWHOGMP,section14)物料(见WHOGMP，第14节)Sourcingofmaterials.物料来源Control,storageandhandlingofmaterials,including:物料的把握、储存和处理，包括：startingmaterials;起始物料packagingmaterials;包装材料intermediateandbulkproducts;中间体和大包装产品finishedproducts;成品returnedandrejectedmaterials;退货和拒收物料reagentsandculturemedia;试剂和培育基referencestandards;比照品wastematerial.废弃物Goodpracticesinproduction(seeWHOGMP,section16)良好的生产标准(见WHOGMP，第16节)Transport,handlinganduseofstartingmaterials,packagingmaterials,andbulkandfinishedproducts.起始物料、包装材料、大包装产品和成品的运输、处理和使用Productionoperationsandimportantparameters(e.g.sampling,quarantine,weighing,processoperationsandconditions,acceptancelimits).〔如：取样、隔离、称量、工艺操作和条件，可承受的限度〕Validation(cess).验证〔如：工艺〕Changecontrolanddeviationreporting.变更把握和偏差报告Qualitycontrol(seeWHOGMP,section17)质量把握(见WHOGMP，第17节)Activitiesofqualitycontrol(includingquarantinecontrol,sampling,chemicalandmicrobialanalysis).质量把握活动〔包括隔离把握、取样、化学和微生物分析〕Organizationandpersonnel.组织和人员Premises.场所Equipmentandinstrumentation.仪器和设备Materials.物料Documentation(e.g.specifications,procedures,reports,records).文件〔如：标准、程序、报告、记录〕Sanitationandhygiene(seeWHOGMP,section3)卫生设施和卫生〔见WHOGMP，第3节〕Proceduresforsanitationand/orcleaning(e.g.ofpremises equipment)andrecords.卫生和/或清洁程序〔如：厂房、设备的〕和记录Personalhygiene.人员卫生Validation(seeWHOGMP,section4)验证(见WHOGMP，第4节)Validationmasterplan.验证主打算Validationandqualificationprotocolsandreportsforqualificationandvalidation(e.g.ofpremises,systems,equipment,process,computer,cleaning,analyticalmethods).〔如：厂房设施、系统、设备、工艺、计算机、清洁的、分析方法〕Stagesofvalidation.验证的状况Typesofvalidation.验证类型Documentation(seeWHOGMP,section15)文件(见WHOGMP，第15节)Documentation(e.g.specifications,procedures,records,protocols,reports).文件〔如：标准、工艺、记录、方案、报告〕Preparation,revisionanddistributionofdocumentation.文件的制定、审核和分发Reportsonproduction,qualitycontrol(includingenvironmentalcontrol),engineeringandotherrelevantareas.(包括环境把握)，工程和其他相关方面〕的报告Complaints(seeWHOGMP,section5)投诉(见WHOGMP，第5节)(a)Procedure,recordsandinvestigation.程序、记录和调查Productrecalls(seeWHOGMP,section6)产品召回(见WHOGMP，第6节)(a)Procedure,recordsandinvestigation.程序、记录和调查Contractproductionandanalysis(seeWHOGMP,section7)托付生产和检验(见WHOGMP，第7节)Res