欧盟cgmp清洁验证方案

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1、XXXX片(lOmg规格〉清洁验证方案CleaningValidationProtocolofXXXXTablets(lOmg)方案起草Preparedby部门/岗位Dept./Position签名Signature起草日期DateQA年(Y)月(M)日(D)方案审核Reviewedby部门/岗位Dept./Position签名Signature审核日期DateQC主管QCSupervisor年(Y)月(M)日(D)QA主管QASupervisor年(Y)月(M)日(D)方案批准Approvedby部门/岗位Dept./Position签名Signature批准日期D

2、ate质量保证部经理QAManager年(Y)月(M)日(D)颁发部门IssuedbyQA生效日期：EffectiveDate分发部门Distributedto制造部(1份)、QC(1份)ProductionDept.(lcopy),QC(1copy)制作备份：2份Copiesprepared:2pcs目录TableofContents1.清洁验证小组人员名单/TeamMemberList32.概述/GeneralIntroduction42」本产品生产中使用的设备/Equipmentsusedinthemanufacturing42.2本产品生产中使用的容器具42.

3、2Utensilsusedinthemanufacturing42.3本产品生产中使用的设备主要材质52.3Constructionmaterialscontactingwithdrugproduct53.》青；吉验个正目白勺/Purposeofcleaningvalidation54.职责/Responsibility64.1制造部/ProductionDept64.2质量保证部/QADept64.3d殳备动力^/EngineeringDept75.方案的执行/Executionofprotocol85.1记录填写要求/FillingofRawData85.2偏差、

4、OOS/OOT的调/Deviation,OOS/OOTinvestigation85.3方案改变的控制程序/ChangeControl8ȀЀࠀ฀฀฀฀฀฀฀฀清洁验证内容Contentofcleaningvalidation9清洁验证的准备工作Preparationbeforecleaningvalidation96.2XXXX残留限度标准的设定/Criteriaofresiduallimit126.3取样程序及取样方法/Samplingprocedureandmethod136.4淸洁验证过程/Theprocessofcleaningvalidation166.5完

5、成此清洁验证方案的所有人员身份资质的确认176.5IdentificationofPersonnelExecutingthisProtocol17ȀЀࠀ฀฀฀฀฀฀฀฀附件及索弓丨Attachmentsandindex18ȀЀࠀ฀฀฀฀฀฀฀฀培训记录/TrainingRecords19附件一制造部及QC本次清洁确认过程中所有使用的设备、仪器、仪表、计量器具等确认或校验情况总结表21Attachment1:listofverificationforproductionequipments&QCinstruments21附件二：取样位置示意图23Attachment2S

6、chematicdiagramforsamplinglocations23附件三：QC化学检测取样记录表24Attachment3SamplingrecordformforQCchemicaltesting24‘7•QC彳J/d/1,0...................................................................................30Attachment4SummaiytableforQCchemicaltestingresults30附件五：QC微生物检测取样记录表36Attachment5Sam

7、plingrecordformforQCMicrobialtesting36附件六：QC微生物检测结果汇总表45••••••••■5Attachment6SummarytableforQCmicrobialtestingresults1•清洁验证小组人员名单/TeamMemberList组长TeamLeader部门Dept.岗位Position姓名Name制造部ProductionDept.业务经理Supervisor小组成员TeamMember部门Dept.岗位Position姓名Name设备动力部EngineeringDept.业务经理Super