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1、XXXX片(lOmg規(guī)格〉清潔驗證方案CleaningValidationProtocolofXXXXTablets(lOmg)方案起草Preparedby部門/崗位Dept./Position簽名Signature起草日期DateQA年(Y)月(M)日(D)方案審核Reviewedby部門/崗位Dept./Position簽名Signature審核日期DateQC主管QCSupervisor年(Y)月(M)日(D)QA主管QASupervisor年(Y)月(M)日(D)方案批準Approvedby部門/崗位Dept./Position簽名Signature批準日期D
2、ate質量保證部經理QAManager年(Y)月(M)日(D)頒發(fā)部門IssuedbyQA生效日期：EffectiveDate分發(fā)部門Distributedto制造部(1份)、QC(1份)ProductionDept.(lcopy),QC(1copy)制作備份：2份Copiesprepared:2pcs目錄TableofContents1.清潔驗證小組人員名單/TeamMemberList32.概述/GeneralIntroduction42」本產品生產中使用的設備/Equipmentsusedinthemanufacturing42.2本產品生產中使用的容器具42.
3、2Utensilsusedinthemanufacturing42.3本產品生產中使用的設備主要材質52.3Constructionmaterialscontactingwithdrugproduct53.》青；吉驗個正目白勺/Purposeofcleaningvalidation54.職責/Responsibility64.1制造部/ProductionDept64.2質量保證部/QADept64.3d殳備動力^/EngineeringDept75.方案的執(zhí)行/Executionofprotocol85.1記錄填寫要求/FillingofRawData85.2偏差、
4、OOS/OOT的調/Deviation,OOS/OOTinvestigation85.3方案改變的控制程序/ChangeControl8???????????清潔驗證內容Contentofcleaningvalidation9清潔驗證的準備工作Preparationbeforecleaningvalidation96.2XXXX殘留限度標準的設定/Criteriaofresiduallimit126.3取樣程序及取樣方法/Samplingprocedureandmethod136.4淸潔驗證過程/Theprocessofcleaningvalidation166.5完
5、成此清潔驗證方案的所有人員身份資質的確認176.5IdentificationofPersonnelExecutingthisProtocol17???????????附件及索弓丨Attachmentsandindex18???????????培訓記錄/TrainingRecords19附件一制造部及QC本次清潔確認過程中所有使用的設備、儀器、儀表、計量器具等確認或校驗情況總結表21Attachment1:listofverificationforproductionequipments&QCinstruments21附件二：取樣位置示意圖23Attachment2S
6、chematicdiagramforsamplinglocations23附件三：QC化學檢測取樣記錄表24Attachment3SamplingrecordformforQCchemicaltesting24‘7?QC彳J/d/1,0...................................................................................30Attachment4SummaiytableforQCchemicaltestingresults30附件五：QC微生物檢測取樣記錄表36Attachment5Sam
7、plingrecordformforQCMicrobialtesting36附件六：QC微生物檢測結果匯總表45????????■5Attachment6SummarytableforQCmicrobialtestingresults1?清潔驗證小組人員名單/TeamMemberList組長TeamLeader部門Dept.崗位Position姓名Name制造部ProductionDept.業(yè)務經理Supervisor小組成員TeamMember部門Dept.崗位Position姓名Name設備動力部EngineeringDept.業(yè)務經理Super
