2025译文双语-第4章-文件管理-mp-vol4-chap4-consultation-guideline-en-zh-CN

Chapter4:Documentation第4章：文件管理Reasonsforchanges:TheGMP/GDPInspectorsWorkingGroupandthePIC/SCommitteejointlyrecommendedthatthecurrentversionofChapter4,ondocumentation,isrevisedtoreflectchangesinregulatoryandmanufacturingenvironments.TherevisedguidelineclarifiesrequirementsandexpectationsfromRegulatoryAuthoritieswithregardstodocumentationandtakesintoaccountrelatedchangesforAnnex11oftheGMPGuide.修订原因：GMP/GDP检查员工作组与PIC/S委员会共同建议修订现⾏第4章文件管理内容，以反映监管与生产环境的变化。修订后的指南明确了监管机构对文件管理的要求与期望，并考虑了GMP指南附录11的相关变更。Documentmap文档结构图Principle原则Datagovernancesystems数据治理体系Riskmanagement风险管理Generalrequirementsfordocumentation文件记录通用要求MasterDocuments主控文件GenerationandControlofDocumentation文件的生成与控制Gooddocumentationpractice良好文件管理规范SignaturesinGMPrelevantdocumentationGMP相关文件中的签名要求Retentionofdocuments文件保存期限DataIntegrityindocumentation文件中的数据完整性HybridSystems混合系统Glossary术语表PRINCIPLE原则4.1.DocumentationconstitutesanessentialpartofthequalityassurancesystemandiskeytooperatingincompliancewithGMPrequirements.Thevarioustypesofdocumentsandmeansusedshouldbefullyunderstoodanddefinedintheregulateduser’spharmaceuticalqualitysystem.4.1文件体系是质量保证系统的重要组成部分，也是符合GMP要求运⾏的关键。各类文件及其使用方式应在受监管用户的药品质量体系中得到充分理解和明确定义。4.2.Itshouldbedeterminedbytheregulateduserwhichlegalprovisionsapplytodocumentationconsideringnewtechnologies,hybridsolutionsandservicesused.4.2.监管用户应自⾏判定适用于采用新技术、混合解决方案及服务时文档管理的法律条款。4.3.Appropriatedocumentationpracticesshouldbeappliedwithrespecttothetypeofdocumentregardlessoftheappliedtechnologyorserviceused.4.3.无论采用何种技术或服务，都应根据文件类型实施适当的文档管理规范。4.4.Thepresentdocumentwassupplementedbyrequirementsregardingnewtechnologies,hybridsolutionsandnewservices,wherebyarisk-basedapproachaselementofadatagovernancesystemisconsideredpivotalforscalabilityofintegritycontrolmeasures.4.4.本⽂件已补充关于新技术、混合解决⽅案及新服务的相关要求，其中基于⻛险的⽅法作为数据治理体系的要素，被视为实现完整性控制措施可扩展性的关键。4.5.Qualityriskmanagementprinciplesshouldbeappliedtoensurethatthepharmaceuticalqualitysystemincludessufficientinstructionaldetails.Itshouldfacilitateacommonunderstandingoftherequirements.Inadditiontoprovidingforrecordingofthevariousprocessesandrisk-basedevaluationofanyobservations,itshoulddemonstratetheongoingapplicationofallrequirements.4.5.应运用质量⻛险管理原则，确保药品质量体系包含充分的指导细则。该体系应促进对要求的统⼀理解，除规定各流程记录及基于⻛险的观察结果评估外，还应持续证明所有要求的贯彻执⾏。4.6.Suitablecontrolsshouldbeimplementedusingarisk-basedapproachtoensuretheaccuracy,integrity,availability,andlegibilityofdocuments.Documentsshouldbefreefromerrorsandavailableinhumanreadableform.4.6.应采用基于⻛险的⽅法实施适当控制措施，确保⽂件的准确性、完整性、可用性及清晰可读。⽂件应⽆差错且以⼈类可读形式提供。4.7.Documentationmayexistinavarietyofforms,includingpaper-based,electronic,orothermeans(e.g.photography,imagery,videoandaudiorecordings).Themainobjectiveofthedocumentationsystemistoestablish,control,monitorandrecordallactivitieswhichdirectlyorindirectlyimpactonallaspectsofthequalityandsafetyofmedicinalproducts,usingariskbasedapproach.4.7.⽂件可采用多种形式存在，包括纸质版、电⼦版或其他形式(如摄影、图像、视频及⾳频记录)。⽂件系统的主要目标是通过基于⻛险的⽅法，建立、控制、监测并记录所有直接或间接影响药品质量与安全各⽅⾯的活动。4.8.Whetherdocumentsarecreated,stored,andmanagedelectronically,paperbased,byothermeansorthroughahybridsystem,theymustmeetthesameGMPrequirementsforlegibility,accuracy,integrity,andcompletenessthroughoutthewholelifecycle.Thisalsoapplieswhendocumentationisoutsourced.4.8.⽆论⽂件是以电⼦形式、纸质形式、其他⽅式创建存储管理，还是通过混合系统处理，在整个生命周期中都必须符合相同的GMP要求，确保清晰可读、准确⽆误、完整可靠。此要求同样适用于外包⽂件管理的情况。4.9.TherearetwoprimarytypesofdocumentationusedtomanageanddemonstrateGMPcompliance:4.9.用于管理和证明GMP符合性的⽂件主要分为两类：i.instructions(directions,requirements)andii.records/reports.⼆、记录/报告DATAGOVERNANCESYSTEMS数据治理体系4.10.Regardlessofhowdocumentsarecreated,handled,stored,andmanaged(i.e.,usingelectronic,paper-based,orhybridsystems),theregulatedusershouldestablishadatagovernancesystemintegraltothepharmaceuticalqualitysystemtodefine,prioritiseandcommunicatetheirdataintegrityriskmanagementactivities.Arrangementsfordatagovernanceshouldbedocumentedandreviewedregularly.4.10⽆论⽂件采用何种⽅式创建、处理、存储和管理(如电⼦系统、纸质系统或混合系统)，受监管用户均应建立与药品质量体系相整合的数据治理体系，用以定义、优先处理并传达其数据完整性⻛险管理活动。数据治理的相关安排应形成⽂件并定期审核。4.11.Regulatedusersshoulddesignandoperateadatagovernancesystemwhichprovidesanacceptablestateofcontrolbasedontheriskassessment,whichisdocumentedwithsupportingrationale.Adatagovernancesystemshouldbeconsistentwiththeprinciplesofqualityriskmanagement.4.11.受监管用户应设计并运⾏⼀套数据治理体系，该体系需基于⻛险评估提供可接受的控制状态，并附有⽀持性理由的⽂件记录。数据治理体系应符合质量⻛险管理原则。4.12.Toensureintegrityofdatathegovernancesystemshouldcovertheentiredatalifecycleandensurecontrolscommensuratewiththeprincipleofqualityriskmanagement.Thedatalifecycleshouldreferto:4.12.为确保数据完整性，治理体系应覆盖整个数据生命周期，并实施与质量⻛险管理原则相匹配的控制措施。数据生命周期包括：i.Creationandrecordingofdata.i.数据的生成与记录ii.Processingof(raw)datatoreported(derived)data.ii.(原始)数据处理为报告用(衍生)数据iii.Verificationofcompleteness,consistencyandaccuracyofalldata(rawandderiveddata).Forderiveddatathetraceabilitywhichallowsreconstructionofalldataprocessingactivitiesshouldbemaintained.iii.验证所有数据(原始数据与衍生数据)的完整性、⼀致性和准确性。对于衍生数据，应保持可追溯性以确保能够重建所有数据处理活动。iv.Decisionmakingrelyingondata(orderiveddata).iv.基于数据(或衍生数据)进⾏决策。v.Retaining,archivingandretrievalofdata.Toprotectitfromlossorunauthorisedalterationitshouldbecommensuratewiththeprinciplesofqualityriskmanagement.v.数据的保存、归档与检索。应根据质量⻛险管理原则采取相应措施，防止数据丢失或未经授权的篡改。vi.Retirementordestructionofdataattheendofthelifecycleinacontrolledmanner.vi.在数据生命周期结束时以受控⽅式淘汰或销毁数据。4.13.Datagovernancesystemsshouldrelyonariskmanagementapproachandconsider:4.13数据治理系统应采用⻛险管理⽅法，并考虑以下因素：i.Datacriticality(impacttodecisionmakingandproductquality)andi.数据关键性(对决策制定和产品质量的影响)以及ii.Datarisk(opportunityfordataalterationanddeletion,andlikelihoodofdetection/visibilityofchangesbytheregulateduser’sroutinereviewprocesses).ii.数据⻛险(数据篡改和删除的可能性，以及受监管用户常规审查流程对变更的检测/可⻅性)4.14.Datagovernancesystemsshouldrelyontheincorporationofsuitablydesignedsystems,theuseoftechnologiesanddatasecuritymeasures,combinedwithspecificexpertisetoensurethatdataintegrityiseffectivelycontrolledoverthedatalifecycle.4.14数据治理系统应依托于合理设计的系统架构，采用适当的技术和数据安全措施，并结合专业领域知识，以确保在数据全生命周期中有效控制数据完整性。4.15.Datagovernancesystemsshouldaddressdataownershipthroughouttheentirelifecycle.4.15.数据治理体系应涵盖数据全生命周期的所有权问题。4.16.Datagovernancesystemsshouldconsiderthedesign,operationandmonitoringofprocessesandsystemstocomplywiththeprinciplesofdataintegrity.4.16.数据治理体系需对流程和系统的设计、运⾏及监控进⾏统筹考量，以确保符合数据完整性原则。4.17.Datagovernancesystemsshouldconsiderriskmitigation.Theeffectivenessofriskmitigationmeasuresshouldbereviewedregularly,regardlessofwhethertheyaretemporaryorpermanent.Residualrisksshouldbereviewedperiodicallyandcommunicatedtomanagement.4.17.数据治理体系应考虑⻛险缓释措施。⽆论临时性或永久性措施，均需定期评估其有效性。残余⻛险应定期审查并向管理层报告。4.18.Datagovernancesystemsshouldconsiderandensuretheperiodicreviewofserviceprovider’sdatamanagementpoliciesandriskcontrolstrategiesintendedtominimisepotentialriskstodataintegrity.Thefrequencyofsuchreviewsshouldbebasedonthecriticalityoftheservicesprovided,usingriskmanagementprinciples.4.18.数据治理体系应确保定期审查服务提供商的数据管理政策及⻛险控制策略，这些策略旨在最大限度降低数据完整性的潜在⻛险。审查频率应基于所提供服务的⻛险等级，运用⻛险管理原则确定。RISKMANAGEMENT风险管理4.19.Theregulatedusershouldadoptarisk-basedapproachindocumentationthroughouttheentirelifecycleofdata,regardlessofthetechnology,hybridsolutionorserviceusedandshoulddemonstrateanunderstandingfordatacriticality,datariskanddataquality.4.19⽆论采用何种技术、混合解决⽅案或服务，监管用户应在数据全生命周期中采用基于⻛险的⽂档管理⽅法，并展现出对数据关键性、数据⻛险和数据质量的理解。4.20.Controlsoverthedatalifecycleshouldbeestablishedwhicharecommensuratewiththeprinciplesofqualityriskmanagement.Thedepthofdatagovernanceandriskmanagementactivitiesshouldbejustifiedandcommensuratewiththeriskstoproductqualityandpatientsafety.4.20应建立与质量风险管理原则相适应的数据生命周期控制措施。数据治理和风险管理活动的深度应与产品质量和患者安全风险相匹配。4.21.Decisionsontheextentofmeasurestoensuredataintegrityshouldbebasedonadocumentedrationaleanddocumentedriskassessmenttakingintoconsiderationdatacriticalityanddatarisk.4.21关于确保数据完整性措施范围的决策应基于⽂件化的基本原理和风险评估，同时考虑数据关键性和数据风险。4.22.Irrespectiveofprocessesusedtogenerateelectronicdata,theymustbeincludedintherequirementsforthequalificationorvalidationoftherelevantcomputerisedsystemsaccordingtoAnnex11.4.22.⽆论采用何种流程生成电⼦数据，都必须根据附录11的要求将其纳⼊相关计算机化系统的确认或验证范围。GENERALREQUIREMENTSFORDOCUMENTATION文件管理通用要求4.23.Thepharmaceuticalqualitysystemshoulddescribealldocumentsrequiredtoensureproductqualityandpatientsafety.Documentsmaybecreated,recorded,provided,approved,communicated,stored,andarchivedelectronically,paperbasedorinahybridsystem.Therelianceonelectronic,paper-basedordifferentmeans,hybridsolutionsorhostedservicesinmaintenanceandretentionofdocumentationrequiresthecompliancewithallEUGMPprovisionsincludingAnnex11ifdecisionmakinginmanufacturing(e.g.batchreleasebasedonin-processcontrolsandprocessanalyticaltechnologies)issupportedbyautomaticvalidationscriptsorartificialintelligence(Annex22).4.23.药品质量体系应规定确保产品质量和患者安全所需的所有⽂件。⽂件可通过电⼦⽅式、纸质⽅式或混合系统创建、记录、提供、批准、传递、存储和归档。在⽂件维护和保存过程中对电⼦⽅式、纸质⽅式、不同⼿段、混合解决⽅案或托管服务的依赖，需符合所有欧盟GMP规定(包括附录11)，特别是当生产决策(例如基于过程控制和过程分析技术的批次放⾏)由自动验证脚本或⼈⼯智能(附录22)⽀持时。4.24.Theaccountabilityfortheintegrityofdocuments,recordsor(raw)dataproducedorprocessed4.24.对生成或处理的⽂件、记录或(原始)数据完整性的责任withartificialintelligenceoranyotherautomaticmeans(e.g.validationscripts)restswiththeregulateduser.使用⼈⼯智能或其他自动化⼿段(如验证脚本)的责任在于受监管用户。4.25.Thesupportbyanyautomaticmeans(e.g.validationscriptsorartificialintelligence)shouldbeincludedinapharmaceuticalqualitysystemregardlessoftheservicelocatedonpremiseorasahostedservice.Therecordscreatedelectronicallyshouldenableatrendanalysisofquality-criticaldata.4.25.任何自动化⼿段(如验证脚本或⼈⼯智能)的⽀持都应纳⼊药品质量体系，⽆论服务是本地部署还是托管服务。电⼦创建的记录应能够对质量关键数据进⾏趋势分析。4.26.Toensuredataintegrity,datawhichisrecordedorprocessedelectronicallyshouldnotbeconvertedtoorstoredinapaperformunlessitmeetstherequirementssetoutinsection13“hybridsystems”ortheconversionisvalidatedorverifiedforaccuracy.4.26.为确保数据完整性，以电⼦⽅式记录或处理的数据不应转换为纸质形式或存储在纸质介质上，除非符合第13节"混合系统"的要求，或该转换经过验证或准确性确认。MASTERDOCUMENTS主控文件4.27.Specificallyrequiredmasterdocuments(notexhaustivelist):4.27.特别要求的主⽂件(非详尽清单)：i.SiteMasterFile:RefertoEUGMPGuidelines,Volume4“ExplanatoryNotesonthepreparationofaSiteMasterFile”.i.场地主⽂件：参⻅欧盟GMP指南第4卷《场地主⽂件编制说明》。ii.ValidationMasterPlan:Adocumentdescribingthekeyelementsofthesitequalificationandvalidationprogram.Masterdocumentsshouldbeevaluatedandreviewedonaregularbasis.ii.验证主计划：描述场地确认与验证计划关键要素的⽂件。主⽂件应定期进⾏评估和审核。iii.Instructions(directions,orrequirements)type:iii.指令(说明或要求)类⽂件：Specification:Refertoglossaryfordefinition规范：术语定义请参考词汇表ManufacturingFormulae,Processing,PackagingandTestingInstruction:Providecompletedetailonallthestartingmaterials,equipment,andcomputerisedsystems(ifany)tobeusedandspecifyallprocessing,packaging,sampling,andtestinginstructionstoensurebatchtobatchconsistency.In-processcontrolsandprocessanalyticaltechnologiestobeemployedshouldbespecifiedwhererelevant,togetherwithacceptancecriteria.制造配⽅、加⼯、包装及检测说明：提供所用全部起始物料、设备及计算机化系统(如适用)的完整细节，并详细说明所有加⼯、包装、抽样和检测规程以确保批次间⼀致性。应酌情说明采用的中间控制及过程分析技术，并附验收标准。Procedures:(OtherwiseknownasStandardOperatingProcedures,orSOPs),documentedsetofinstructionsforperformingandrecordingoperations.sProtocol:definedsetofactivitiestoprovideinstructionsforperformingandrecordingcertaindiscreetoperations.⽅案：为执⾏和记录特定独立操作而定义的指令性活动集合。Technical/QualityAgreement:Writtenproofofagreementbetweencontractgiversandacceptorsforoutsourcedactivities.技术/质量协议：委托⽅与受托⽅就外包活动达成的书面证明协议。iv.Record/Reporttype:四、记录/报告类型：Record:Provideevidenceofvariousactionstakentodemonstratecompliancewithinstructions,e.g.activities,events,investigations,andinthecaseofmanufacturedbatchesahistoryofeachbatchofproduct,includingitsdistribution.Recordsincludetherawdatawhichisusedtogenerateotherrecords.Forelectronicrecordsregulatedusersshoulddefinewhichdataaretobeusedasrawdata.Atleast,alldataonwhichqualitydecisionsarebasedshouldbedefinedasrawdata.记录：提供各类⾏动的证据以证明符合操作要求，例如活动、事件、调查，以及生产批次的产品历史记录(包括其分销情况)。记录包含用于生成其他记录的原始数据。对于电⼦记录，受监管用户应明确界定哪些数据作为原始数据。至少应将所有基于质量决策的数据定义为原始数据。Recordscanalsoexistashybridrecordswhichisacombinationofpaperrecords,electronicrecordsorbyothermeans.Thecompletenessandintegrityofrecords,includingallrelevantrawdataandmetadatashouldbeensuredandprotectedbasedonrisk.记录也可以作为混合记录存在，即纸质记录、电⼦记录或其他⽅式的组合。应根据风险确保并保护记录的完整性和准确性，包括所有相关原始数据和元数据。CertificateofAnalysis:Provideasummaryoftestingresultsonsamplesofproductsormaterialstogetherwiththeevaluationforcompliancetoastatedspecification.分析证书：提供产品或材料样本的检测结果摘要，并评估是否符合规定标准。Report:Documenttheconductofexercises,studies,assessments,projectsorinvestigations,togetherwithresults,conclusionsandrecommendations.包括结果、结论和建议。Specifications质量标准4.28.Thereshouldbeapprovedandupdatedspecificationsforstartingandpackagingmaterials,intermediate,bulk,finishedproducts,processaidsandotherqualitycriticalmaterial,asapplicable.Specificationsshouldincludeallattributeswhicharerelevantforproductqualityoneachstageofmaterialormanufacture.4.28应制定并更新起始物料、包装材料、中间体、半成品、成品、⼯艺助剂及其他关键质量物料的批准标准(如适用)。质量标准应包含各生产阶段中与产品质量相关的所有属性。Specificationsforstartingandpackagingmaterials起始物料和包装材料的规格要求4.29.Specificationsforstartingandprimaryorprintedpackagingmaterialsshouldincludetheproductanditsreferencecode,ifapplicable:4.29.起始物料及初级或印刷包装材料的规格应包括产品名称及其参考代码(如适用)：i.Adescriptionofthematerials,including:Thedesignatednameandtheinternalcodereference.指定的名称和内部代码参考Thereference,ifany,toapharmacopeialmonograph.若有提及，应参考药典专论。Theapprovedsuppliersand,ifapplicable,theoriginalproducerofthematerial.经批准的供应商，以及适用时该物料的原始生产商。Aspecimenofprintedmaterials.印刷材料的样本。ii.Directionsforsamplingandtesting.ii.取样与检测指导。iii.Qualitativeandquantitativerequirementswithacceptancelimits.iii.包含验收限度的定性和定量要求iv.Storageconditionsandprecautions.iv.储存条件和注意事项v.Themaximumperiodofstoragebeforere-examination.v.复验前的最长储存期限Specificationsforintermediateandbulkproducts中间产品和散装产品的质量标准4.30.Specificationsforintermediateandbulkproductsshouldbeavailableforcriticalstepsorifthesearepurchasedordispatched.Thespecificationsshouldbesimilartospecificationsforstartingmaterialsorforfinishedproducts,asappropriate.4.30中间产品和待包装产品的质量标准应当针对关键生产步骤制定，或在采购或发运时提供。这些标准应与起始物料或成品质量标准相适应。Specificationsforfinishedproducts成品质量标准4.31.Specificationsforfinishedproductsshouldincludeorprovidereferenceto:4.31成品质量标准应包括或引用以下内容：vi.Thedesignatednameoftheproductandthecodereferencewhereapplicable.vi.产品的法定名称及适用时的代码编号vii.Theformula.vii.配方。viii.Adescriptionofthepharmaceuticalformandpackagedetails.viii.药品剂型及包装规格说明。ix.Directionsforsamplingandtesting.ix.取样与检测⽅法说明。x.Thequalitativeandquantitativerequirements,withtheacceptancelimits.x.定性定量要求及验收标准。xi.Thestorageconditionsandanyspecialhandlingprecautions,whereapplicable.xi.适用情况下的储存条件及特殊处理注意事项xii.Theshelf-life.xii.有效期ManufacturingFormulaandProcessingInstructions生产配方与加工规程4.32.Approved,writtenManufacturingFormulaandProcessingInstructionsshouldexistforeachproductandbatchsizetobemanufactured.4.32.每种产品及其生产批量均应制定经批准的书面生产配⽅与加工规程4.33.TheManufacturingFormulashouldinclude:4.33.生产配⽅应包括：i.Thenameoftheproduct,withaproductreferencecoderelatingtoitsspecification.i.产品名称及与其规格对应的产品参考代码ii.Adescriptionofthepharmaceuticalform,strengthoftheproductandbatchsize.ii.对药品剂型、规格及批量的描述iii.Alistofallstartingmaterialstobeused,withtheamountofeach,described;iii.所用全部起始物料的清单，并注明各物料用量mentionshouldbemadeofanysubstancethatmaydisappearwhileprocessing,ofprocessingaidsneededoranyothermaterialrelevantforproductquality.应说明在加工过程中可能消失的任何物质、所需的加工助剂或与产品质量相关的其他材料。iv.Astatementoftheexpectedfinalyieldwiththeacceptablelimits,andofrelevantintermediateyields,whereapplicable.iv.说明预期最终产率及其可接受限度，如适用还应说明相关中间产率。4.34.TheProcessingInstructionsshouldinclude:4.34.加工说明应包括：i.Astatementoftheprocessinglocationandtheprincipalequipmenttobeused.i.说明加工地点及将使用的主要设备。ii.Themethods,orreferencetothemethods,tobeusedforpreparingthecriticalequipment(e.g.cleaning,assembling,calibrating,sterilising).ii.用于关键设备准备的⽅法或⽅法参考(如清洁、组装、校准、灭菌)。iii.Checksthattheequipmentandworkstationareclearofpreviousproducts,documentsormaterialsnotrequiredfortheplannedprocess,andthatequipmentiscleanandsuitableforuse.iii.确认设备和工作站已清除与当前生产⽆关的上⼀批产品、⽂件或物料，且设备已清洁并处于适用状态。iv.Detailedstepwiseprocessinginstructions[e.g.checksonmaterials,pre-treatments,sequenceforaddingmaterials,criticalprocessparameters(time,tempetc)].iv.详细的分步操作指令[包括物料检查、预处理、投料顺序、关键工艺参数(时间、温度等)]。v.Theinstructionsforanyin-processcontrolswiththeirlimits.v.中间控制指标及其限值的操作说明。vi.Wherenecessary,therequirementsforbulkstorageoftheproducts;includingthecontainer,labellingandspecialstorageconditionswhereapplicable.vi.必要时，应规定产品批量储存的要求；包括适用的容器、标签及特殊储存条件。vii.Anyspecialprecautionstobeobserved.vii.需遵守的任何特殊注意事项。PackagingInstructions包装说明4.35.ApprovedPackagingInstructionsforeachproduct,packsizeandtypeshouldexist.Theseshouldinclude,orhaveareferenceto,thefollowing:4.35.每种产品、包装规格和类型均应制定经批准的包装说明。这些说明应包含或引用以下内容：i.Nameoftheproduct;includingthebatchnumberofbulkandfinishedproduct.i.产品名称；包括原料药和成品的批号。ii.Descriptionofitspharmaceuticalform,andstrengthwhereapplicable.ii.药品剂型说明，如适用需注明规格强度。iii.Thepacksizeexpressedintermsofthenumber,weightorvolumeoftheproductinthefinalcontainer.iii.包装规格，以最终容器内产品的数量、重量或体积表示。iv.Acompletelistofallthepackagingmaterialsrequired,includingquantities,sizesandtypes,withthecodeorreferencenumberrelatingtothespecificationsofeachpackagingmaterial.iv.所需全部包装材料的完整清单，包括数量、尺⼨和类型，并附各包装材料规格对应的代码或参考编号。v.Whereappropriate,anexampleorreproductionoftherelevantprintedpackagingmaterials,andspecimensindicatingwheretoapplybatchnumberreferences,andshelflifeoftheproduct.五、如适用，应提供相关印刷包装材料的样本或复制品，以及标明产品批号标识位置和有效期的样品。vi.Checksthattheequipmentandworkstationareclearofpreviousproducts,documentsormaterialsnotrequiredfortheplannedpackagingoperations(lineclearance),andthatequipmentiscleanandsuitableforuse.六、检查设备和⼯作站是否已清除与计划包装操作⽆关的先前产品、⽂件或材料(产线清场)，并确认设备已清洁且适合使用。vii.Checksonfunctioningofanyelectroniccodereaders,labelcountersorsimilardevices.七、检查电⼦条码阅读器、标签计数器或类似设备的功能是否正常。viii.Specialprecautionstobeobserved,includingacarefulexaminationoftheareaandequipmentinordertoascertainthelineclearancebeforeoperationsbegin.⼋、需采取的特殊预防措施，包括在操作开始前对区域和设备进⾏仔细检查以确认产线清场情况。ix.Adescriptionofthepackagingoperation,includinganysignificantsubsidiaryoperations,andequipmenttobeused.ix.包装操作说明，包括所有重要辅助⼯序及拟使用设备。x.Detailsofin-processcontrolswithinstructionsforsamplingandacceptancelimits.x.中间控制细节，含取样规程与验收标准。BatchProcessingRecord批生产记录4.36.ABatchProcessingRecordshouldbekeptforeachbatchprocessed.Itshouldbebasedon4.36.每批产品均应保存批生产记录，记录应基于therelevantpartsofthecurrentlyapprovedManufacturingFormulaandProcessingInstructions,andshouldcontainthefollowinginformation:现⾏批准的制造配⽅和⼯艺规程的相关部分，并应包含以下信息：i.Thenameandbatchnumberoftheproduct.i.产品名称及批号ii.Datesandtimesofcommencement,ofsignificantintermediatestagesandofcompletionofproduction.ii.生产开始⽇期和时间、重要中间阶段及生产完成的⽇期和时间iii.Identification(initials)oftheoperator(s)whoperformedeachsignificantstepoftheprocessand,whereappropriate,identification(initials)ofthepersonwhocheckedtheseoperations.iii.执⾏每个重要工艺步骤的操作⼈员标识(姓名首字母)，以及适当时对核查这些操作的⼈员的标识(姓名首字母)iv.Thebatchnumberand/oranalyticalcontrolnumberaswellasthequantitiesofeachstartingmaterialweighed(includingthebatchnumberandamountofanyrecoveredorreprocessedmaterialadded).iv.每批原料药的批号和/或分析控制号，以及各起始物料的称取量(包括所添加的任何回收或返工物料的批号及数量)。v.Anyrelevantprocessingoperationoreventandmajorequipmentused.v.所有相关加工操作或事件，以及使用的主要设备。vi.Arecordofthein-processcontrolsandtheinitialsoftheperson(s)carryingthemout,andtheresultsobtained.vi.过程控制记录、执⾏⼈员姓名首字母及所得结果。vii.Theproductyieldobtainedatdifferentandpertinentstagesofmanufacture.vii.生产过程中各关键阶段获得的产品收率。viii.Notesonspecialproblemsincludingdetails,withsignedauthorisationforanydeviationfromtheManufacturingFormulaandProces