工程管理合同(范本)

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.............................................................................................4A.TheProduct产品..................................................................................................4B.TheProcess工艺...................................................................................................5C.TheFacilities设备................................................................................................5D.ThePeople人员....................................................................................................6E.TheQualityManagementDepartment质量管理部门.........................................6F.TheRegulatoryAuthorities监管机构..................................................................7G.TheRegulations法规............................................................................................8II.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...................................................................13E.Reality实际.........................................................................................................15III.THEREGULATIONSFORQUALITY质量法规................错误!未定义书签。Introduction:TheEmergenceofSpecificRegulationsforAPIs导言：API具体法规的出现....................................................................................错误!未定义书签。1.ICHQ7ASectionI:‘‘Introduction’’第一部分：简介..........错误!未定义书签。2.ICHQ7ASection2:‘‘QualityManagement’’第二部分质量管理.错误!未定义书签。3.ICHQ7ASection3:‘‘Personnel’’第三部分人员...................错误!未定义书签。4.ICHQ7ASection4:‘‘BuildingsandFacilities’’第四部分厂房和设施错误!未定义书签。5.ICHQ7ASection5:‘‘ProcessEquipment’’第五部分工艺设备错误!未定义书签。6.ICHQ7ASection6:‘‘DocumentsandRecords’’第六部分文件和记录..错误!未定义书签。7.ICHQ7ASection7:‘‘MaterialsManagement’’第7部分物料管理................338.ICHQ7ASection8:‘‘ProductionandIn-ProcessControls’’第8部分产品和过程控制......................................................................................................................369.ICHQ7ASection9:‘‘PackagingandIdentificationLabelingofAPIsandIntermediates’’第9部分原料药和中间体的包装和标识标签.......................3910.ICHQ7ASection10:‘‘StorageandDistribution’’储存和发运...................4111.ICHQ7ASection11:‘‘LaboratoryControls’’第11部分实验室控制...4212.ICHQ7ASection12:‘‘Validation’’...............................................................4213.ICHQ7ASection13:‘‘ChangeControl’’第13部分变更控制..................4714.ICHQ7ASection14:‘‘RejectionandRe-UseofMaterials’’第14部分物料的拒收和再用..........................................................................................................4915.ICHQ7ASection15:‘‘ComplaintsandRecalls’’第15部分投诉与召回.5216.ICHQ7ASection16:‘‘ContractManufacturers(IncludingLaboratories)’’第16部分协议制造商（包括实验室）..............................................................54IV.THEQUALITYCONTROLANDQUALITYASSURANCEDEPARTMENT质量控制和质量保证部...............................................................54I.INTRODUCTION介绍Thequalityofactivepharmaceuticalingredients(APIs)isdefinedasmeetingtheappropriatespecificationsfortheAPIandbeingproducedinafacilitycompliantwithICHguidelines‘‘Q7A’’andFDA’scurrentgoodmanufacturingpractices(cGMPs)regulations.MostcountriesregulatethemanufactureofAPIs.TheseregulationsrequireatotalsystemsapproachtoassuringanAPIhastheappropriatelevelofquality.Allcomponentsinthissystemmustbeproperlydesigned,validated,maintained,andoperatedtoallowthemanufacturertoassuretheAPIconsistentlymeetsqualityrequirements.Thegeneralcomponentsofthesystemaretheprocess,facilities,andthepeople.Thischapterconcernsthesecomponents,aswellastheproductqualityitself,theregulations,andthequalitymanagement(QM)department.活性药物成分（APIs）的质量应被定义为符合相应的API规范，并且正在建设中的设施应符合ICH指南'Q7A'和FDA现行的动态药品生产管理规范（cGMP）的规定。大多数国家对原料药的生产制造都有规定。这些法规要求有一个总的系统方法来保证API的质量在适当水平。这个系统中的所有组件必须经过正确的设计，验证，维护和操作，以保证制造商的API始终符合质量要求。该系统中普遍的组件包含工艺过程、设施和人员。本章内容包括这些组件，以及产品质量本身，法规条例和质量管理部（QM）。A.TheProduct产品ThequalityofanAPIisdeterminedbytwofactors:itsconformancetopre-establishedspecificationsandwhetheritisproducedaccordingtoadocumentedvalidatedprocessinacGMPcompliantfacility.TheAPImustpossessappropriatechemicalandphysicalattributestoassurethatitdeliverstheintendedpharmacologicaleffect.Thechemicalattributesdescribetheappropriatepurityandimpuritylimits.Impurityspecificationsareestablishedfromclinicaltoxicologicalstudiesandarealsobasedonreasonableminimumsexpectedfromregulatoryauth