EUGMP第六章节质量控制-qualitycontrol翻译

Chapter6:QualityControl第1部分第6章：质量控制Legalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective2003/94/ECformedicinalproductsforhumanuseandDirective91/412/EECforveterinaryuse.出版详细指南的法律依据：指令2001/83/EC第47条关于人药统一编码和2001/82/EC第51条关于兽药统一编码规定。本文对指令2003/94/EC中人药和91/412/EEC中兽药的药品GMP原则和指南解释提供指南。Statusofthedocument:Revision文件状态：修订Reasonsforchanges:变更理由InclusionofanewsectionontechnicaltransferoftestingmethodsandotheritemssuchasOutOfSpecificationresults.包括检验方法的技术转移作为新章节，包括其它项目例如OOT结果。Deadlineforcomingintooperation:1October2014生效日期：2014年10月1日Principle原则ThischaptershouldbereadinconjunctionwithallrelevantsectionsoftheGMPguideQualityControlisconcernedwithsampling,specificationsandtestingaswellastheorganisation,documentationandreleaseprocedureswhichensurethatthenecessaryandrelevanttestsarecarriedout,andthatmaterialsarenotreleasedforuse,norproductsreleasedforsaleorsupply,untiltheirqualityhasbeenjudgedsatisfactory.QualityControlisnotconfinedtolaboratoryoperations,butmustbeinvolvedinalldecisionswhichmayconcernthequalityoftheproduct.TheindependenceofQualityControlfromProductionisconsideredfundamentaltothesatisfactoryoperationofQualityControl.本章应与GMP指南中所有相关章节一起解读。质量控制主要关注取样、质量标准和检测，同时也与组织机构、文件记录和放行程序相关，这些程序保证了必要和相关的测试。只有当产品和物料的质量被判定为可以接受时，物料才可以放行使用，产品才可以放行销售。质量控制不仅局限于化验室操作，还必须包括所有可能与产品质量相关的其它决定。质量控制独立于生产被认为是质量控制可以令人满意地操作的基础。General通则6.1EachholderofamanufacturingauthorisationshouldhaveaQualityControlDepartment.Thisdepartmentshouldbeindependentfromotherdepartments,andundertheauthorityofapersonwithappropriatequalificationsandexperience,whohasoneorseveralcontrollaboratoriesathisdisposal.AdequateresourcesmustbeavailabletoensurethatalltheQualityControlarrangementsareeffectivelyandreliablycarriedout.每一个生产许可持有人均应具有一个质量控制部门。该部门应独立于其它部门，由一个具有相应资质和经验的人管理，他/她可以管理一个或几个化验室。化验室应具有充分的资源，以保证所有检测要求能有效可靠地实施。6.2TheprincipaldutiesoftheheadofQualityControlaresummarisedinChapter2.TheQualityControlDepartmentasawholewillalsohaveotherduties,suchastoestablish,validateandimplementallqualitycontrolprocedures,overseethecontrolofthereferenceand/orretentionsamplesofmaterialsandproductswhenapplicable,ensurethecorrectlabellingofcontainersofmaterialsandproducts,ensurethemonitoringofthestabilityoftheproducts,participateintheinvestigationofcomplaintsrelatedtothequalityoftheproduct,etc.Alltheseoperationsshouldbecarriedoutinaccordancewithwrittenproceduresand,wherenecessary,recorded.质量控制负责人基本职责在第2章里进行了概括。质量控制部门作为一个整体，还具有其它职责，例如建立、验证和实施所有质量控制程序，监督物料和产品的对照和/或留样，保证物料和产品容器上标签正确，保证对产品稳定性进行监控，参与和产品质量相关的客诉的调查等等。所有这些操作均应根据书面程序进行，必要时，应进行记录。6.3Finishedproductassessmentshouldembraceallrelevantfactors,includingproductionconditions,resultsofin-processtesting,areviewofmanufacturing(includingpackaging)documentation,compliancewithFinishedProductSpecificationandexaminationofthefinalfinishedpack.成品的评估应综合所有相关的因素，包括生产条件、中控检测结果、生产（包括包装）文件审核、成品符合质量标准和最终包装检查。6.4QualityControlpersonnelshouldhaveaccesstoproductionareasforsamplingandinvestigationasappropriate.质量控制人员应有权限进入生产区域进行取样，及适当的调查。GoodQualityControlLaboratoryPractice优良质量控制化验室规范6.5ControllaboratorypremisesandequipmentshouldmeetthegeneralandspecificrequirementsforQualityControlareasgiveninChapter3.Laboratoryequipmentshouldnotberoutinelymovedbetweenhighriskareastoavoidaccidentalcross-contamination.Inparticular,themicrobiologicallaboratoryshouldbearrangedsoastominimizeriskofcross-contamination.化验室设施和设备应符合第3章里给出的QC区域通用和特殊要求。为避免交叉污染事故，化验室设备一般不应该设计为需要常常在高风险区域之间移来移去。特别是微生物化验室的布置，应尽可能将交叉污染的风险降至最低。6.6Thepersonnel,premises,andequipmentinthelaboratoriesshouldbeappropriatetothetasksimposedbythenatureandthescaleofthemanufacturingoperations.Theuseofoutsidelaboratories,inconformitywiththeprinciplesdetailedinChapter7,ContractAnalysis,canbeacceptedforparticularreasons,butthisshouldbestatedintheQualityControlrecords.化验室的人员、设施、设备应与其检验任务和生产规模相当。在有特殊原因情况下，可以使用外部分化验室，但应符合第7章“外包分析”中的原则，并要在质量控制记录上说明。Documentation文件6.7LaboratorydocumentationshouldfollowtheprinciplesgiveninChapter4.AnimportantpartofthisdocumentationdealswithQualityControlandthefollowingdetailsshouldbereadilyavailabletotheQualityControlDepartment:化验室文件应符合第4章中给定的原则。这部分文件一个重要部分与质量控制相关，质量控制部门应很容易获得以下详细信息i.Specifications;质量标准ii.Proceduresdescribingsampling,testing,records(includingtestworksheetsand/orlaboratorynotebooks),recordingandverifying;描述取样、检测、记录（包括检测原始记录表和/或化验室笔记本）、记录和确认情况iii.Proceduresforandrecordsofthecalibration/qualificationofinstrumentsandmaintenanceofequipment;仪器校正/确认，设备维保程序和记录iv.AprocedurefortheinvestigationofOutofSpecificationandOutOfTrendresults;OOS和OOT结果调查程序v.Testingreportsand/orcertificatesofanalysis;检测报告和/或分析报告vi.Datafromenvironmental(air,waterandotherutilities)monitoring,whererequired;环境（空气、水和其它设施）监控数据，必要时vii.Validationrecordsoftestmethods,whereapplicable.检验方法的验证记录，必要时6.8AnyQual