7QualityAssuranceandControl质量保证和质量控制MICHAELC.VANDERZWANPharmaceuticalTechnical,RochePharmaceuticals,Basel,SwitzerlandI.Introduction介绍...........................235II.DefiningandAssuringtheQualityoftheActivePharmaceuticalIngredient原料药质量的定义和保证..................240III.TheRegulationsforQuality质量监管.................245IV.TheQualityControlandQualityAssuranceDepartment质量控制和质量保证.................273AppendixA附录...........................280目录I.INTRODUCTION介绍.............................................................................................2A.TheProduct产品...................................................................................................3B.TheProcess工艺...................................................................................................4C.TheFacilities设备.................................................................................................5D.ThePeople人员....................................................................................................5E.TheQualityManagementDepartment质量管理部门..........................................6F.TheRegulatoryAuthorities监管机构...................................................................7G.TheRegulations法规............................................................................................7II.DEFININGANDASSURINGTHEQUALITYOFTHEACTIVEPHARMACEUTICALINGREDIENT原料药质量的定义和质量保证.................9A.DefiningtheAPIQuality原料药质量的界定....................................................10B.TestingtheAPIforItsDefinedAttributes原料药定义的属性测试..................11C.DesigningQualityintotheProcess工艺中的质量设计.....................................12D.ValidationoftheProcess工艺验证....................................................................14E.Reality实际.........................................................................................................16III.THEREGULATIONSFORQUALITY质量法规...............................................17Introduction:TheEmergenceofSpecificRegulationsforAPIs导言：API具体法规的出现..................................................................................................................171.ICHQ7ASectionI:‘‘Introduction’’第一部分：简介........................................212.ICHQ7ASection2:‘‘QualityManagement’’第二部分质量管理...................223.ICHQ7ASection3:‘‘Personnel’’第三部分人员.................................................244.ICHQ7ASection4:‘‘BuildingsandFacilities’’第四部分厂房和设施...............265.ICHQ7ASection5:‘‘ProcessEquipment’’第五部分工艺设备......................296.ICHQ7ASection6:‘‘DocumentsandRecords’’第六部分文件和记录........317.ICHQ7ASection7:‘‘MaterialsManagement’’第7部分物料管理................368.ICHQ7ASection8:‘‘ProductionandIn-ProcessControls’’第8部分产品和过程控制......................................................................................................................409.ICHQ7ASection9:‘‘PackagingandIdentificationLabelingofAPIsandIntermediates’’第9部分原料药和中间体的包装和标识标签.........................4410.ICHQ7ASection10:‘‘StorageandDistribution’’储存和发运...................4511.ICHQ7ASection11:‘‘LaboratoryControls’’第11部分实验室控制.....4612.ICHQ7ASection12:‘‘Validation’...
