ICH-Q7a原料药的GMP指南(中英对照).doc

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1、Q7aQ7a（中英文对照）FDA原料药GMP指南TableofContents目录1.INTRODUCTION1.简介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生产作业的职责2.4Int

2、ernalAudits(SelfInspection)2.4内部审计（自检）2.5ProductQualityReview2.5产品质量审核3.PERSONNEL3.人员3.1PersonnelQualifications3.人员的资质3.2PersonnelHygiene3.2人员卫生3.3Consultants3.3顾问4.BUILDINGSANDFACILITIES4.建筑和设施4.1DesignandConstruction4.1设计和结构4.2Utilities4.2公用设施4.3Water4.3水4.4Containment

3、4.4限制4.5Lighting4.5照明4.6SewageandRefuse4.6排污和垃圾4.7SanitationandMaintenance4.7卫生和保养5.PROCESSEQUIPMENT5.工艺设备5.1DesignandConstruction5.1设计和结构5.2EquipmentMaintenanceandCleaning5.2设备保养和清洁5.3Calibration5.3校验5.4ComputerizedSystems5.4计算机控制系统6.DOCUMENTATIONANDRECORDS6.文件和记录6.1Doc

4、umentationSystemandSpecifications6.1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,APILabelingandPackagingMaterials6.3原料、中间体、原料药的标签和包装材料的记录6.4MasterProductionInstructions(MasterProductionandControlRecords)6.4生产工艺规程（主生产和控制记录）6

5、.5BatchProductionRecords(BatchProductionandControlRecords)6.5批生产记录（批生产和控制记录）69Q7a6.6LaboratoryControlRecords6.6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控制通则7.2ReceiptandQuarantine7.2接收和待验7.3SamplingandTestingofIncomin

6、gProductionMaterials7.3进厂物料的取样与测试7.4Storage7.4储存7.5Re-evaluation7.5复验8.PRODUCTIONANDIN-PROCESSCONTROLS8.生产和过程控制8.1ProductionOperations8.1生产操作8.2TimeLimits8.2时限8.3In-processSamplingandControls8.3工序取样和控制8.4BlendingBatchesofIntermediatesorAPIs8.4中间体或原料药的混批8.5ContaminationCo

7、ntrol8.5污染控制9.PACKAGINGANDIDENTIFICATIONLABELINGOFAPIsANDINTERMEDIATES9.原料药和中间体的包装和贴签9.1General9.1总则9.2PackagingMaterials9.2包装材料9.3LabelIssuanceandControl9.3标签发放与控制9.4PackagingandLabelingOperations9.4包装和贴签操作10.STORAGEANDDISTRIBUTION10.储存和分发10.1WarehousingProcedures10.1入库

8、程序10.2DistributionProcedures10.2分发程序11.LABORATORYCONTROLS11.实验室控制11.1GeneralControls11.1控制通则11.2Testing