ICHQ7(中英文)

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEGOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSQ7CurrentStep4versiondated10November2000ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.中英文对照Q7DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005Q7AApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.19July2000Q7CurrentStep4versionQ7AApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.10November2000Q7GOODMANUFACTURINGPRACTICEGUIDEFORACTIVEPHARMACEUTICALINGREDIENTSICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon10November2000,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICHTableofContents目录1.INTRODUCTION1.前言1.1Objective1.1目的1.2RegulatoryApplicability1.2法规的适用性1.3Scope1.3范围2.QUALITYMANAGEMENT2.质量管理2.1Principles2.1总则2.2ResponsibilitiesoftheQualityUnit(s)2.2质量部门的责任2.3ResponsibilityforProductionActivities2.3生产的职责2.4InternalAudits(SelfInspection)2.4内部审计（自检）2.5ProductQualityReview2.5产品质量回顾3.PERSONNEL3.人员3.1PersonnelQualifications3.1人员资格3.2PersonnelHygiene3.2个人卫生3.3Consultants3.3顾问4.BUILDINGSANDFACILITIES4.建筑和设施4.1DesignandConstruction4.1设计和建造4.2Utilities4.2公用设施4.3Water4.3水4.4Containment4.4特殊限制4.5Lighting4.5照明4.6SewageandRefuse4.6污物和废弃物4.7SanitationandMaintenance4.7卫生和维护5.PROCESSEQUIPMENT5.工艺设备5.1DesignandConstruction5.1设计和建造5.2EquipmentMaintenanceandCleaning5.2设备维护和清洁5.3Calibration5.3校验5.4ComputerizedSystems5.4计算机控制系统6.DOCUMENTATIONANDRECORDS6.文件和记录6.1DocumentationSystemandSpecifications6.1文件系统和质量标准6.2EquipmentcleaningandUseRecord6.2设备的清洁和使用记录6.3RecordsofRawMaterials,Intermediates,6.3原料、中间体、原料药的标签和包装材料的记录APILabelingandPackagingMaterials6.4MasterProductionInstructions6.4主生产指令（主生产和控制记录）(MasterProductionandControlRecords)6.5BatchProductionRecords6.5批生产记录（批生产和控制记录）(BatchProductionandControlRecords)6.6LaboratoryControlRecords6.6实验室控制记录6.7BatchProductionRecordReview6.7批生产记录审核7.MATERIALSMANAGEMENT7.物料管理7.1GeneralControls7.1一般要求7.2ReceiptandQuarantine7.2接收和待验7.3SamplingandTestingofIncomingProductionMaterials7.3来料的取样与检测7.4Storage7.4储存7.5Re-evaluation7.5再评价8.PRODUCTIONANDIN-PROCESSCONTROLS8.生产管理和生产过程控制8.1ProductionOperations8.1生产管理8.2TimeLimits8.2时限8.3In-processSamplingandControls8.3生产过程中的取样和控制8.4BlendingBatchesofIntermediatesorAPIs8.4中间体或原料药的混批8.5ContaminationControl8.5污染控制9.PACKAGINGANDIDENTIFICATION9.原料药和中间体的包装和贴签LABELINGOFAPIsANDINTERMEDIATES9.1General9.1通则9.2PackagingMaterials9.2包装材料9.3LabelIssuanceandControl9.3标签发放与管理9.4PackagingandLabelingOperations9.4包装和贴签管理10.STORAGEANDDISTRIBUTION10.储存和分发10.1WarehousingProcedures10.1入库程序10.2DistributionProcedures10.2分发程序11.LABORATORYCONTROLS11.实验室管理11.1GeneralControls11.1通则11.2TestingofIntermediatesandAPIs11.2中间体和原料药的检测11.3ValidationofAnalyticalProcedures11.3分析方法的验证11.4CertificatesofAnalysis11.4检验报告11.5StabilityMonitoringofAPIs11.5原料药的稳定性考察11.6ExpiryandRetestDating11.6有效期和复验期11.7Reserve/RetentionSamples11.7留样12.VALIDATION12.验证12.1ValidationPolicy12.1验证方针12.2ValidationDocumentation12.2验证文件12.3Qualification12.3确认12.4ApproachestoProcessValidation12.4工艺验证的方法12.5ProcessValidationProgram12.5工艺验证的程序12.6PeriodicReviewofValidatedSystems12.6对已验证的系统的定期回顾12.7CleaningValidation12.7清洗验证12.8ValidationofAnalyticalMethods12.8分析方法的验证13.CHANGECONTROL13.变更控制14.REJECTIONANDRE-USEOFMATERIALS14.物料的拒收和再利用14.1Rejection14.1拒收14.2Reprocessing14.2返工14.3Reworking14.3重新加工14.4RecoveryofMaterialsandSolvents14.4物料与溶剂的回收14.5Returns14.5退货15.COMPLAINTSANDRECALLS15.投诉与召回16.CONTRACTMANUFACTURERS16.协议生产商（包括实验室）(INCLUDINGLABORATORIES)17.AGENTS,BROKERS,TRADERS,DISTRIBUTORS,17.代理商、经纪人、贸易商、经销商、重新包装者REPACKERS,ANDRELABELLERS和重新贴签者17.1Applicability17.1适用性17.2TraceabilityofDistributedAPIsandIntermediates17.2已分发的原料药和中间体的可追溯性17.3QualityManagement17.3质量管理17.4Repackaging,Relabeling,andHoldingofAPIsandIntermediates17.4原料药和中间体的重新包装、重新贴签和待检17.5Stability17.5稳定性17.6TransferofInformation17.6信息的传达17.7HandlingofComplaintsandRecalls17.7投诉和召回的处理17.8HandlingofReturns17.8退货的处理18.SpecificGuidanceforAPIsManufacturedbyCell18.用细胞繁殖/发酵生产的原料药的特殊指南Culture/Fermentation18.1General18.1总则18.2CellBankMaintenanceandRecordKeeping18.2细胞库的维护和记录的保存18.3CellCulture/Fermentation18.3细胞繁殖/发酵18.4Harvesting,IsolationandPurification18.4收取、分离和精制18.5ViralRemoval/Inactivationsteps18.5病毒的去除/灭活步骤19.APIsforUseinClinicalTrials19.用于临床研究的原料药19.1General19.1总则19.2Quality19.2质量19.3EquipmentandFacilities19.3设备和设施19.4ControlofRawMaterials19.4原料的控制19.5Production19.5生产19.6Validation19.6验证19.7Changes19.7变更19.8LaboratoryControls19.8实验室控制19.9Documentation19.9文件20.Glossary20.术语1.INTRODUCTION1.简介1.1Objective1.1目的Thisdocumentisintendedtoprovideguidanceregardinggoodmanufacturingpractice(GMP)forthemanufacturingofactivepharmaceuticalin