上海金冀商务咨询有限公司,ShanghaiJinjiBusinessConsultingCo.,Ltd文件编号：固体车间清洁验证方案CleaningvalidationMasterPlanforSolidDosageWorkshop立项部门：质量保证部InitiationDepartment:QualityAssuranceDepartment工艺验证小组负责人：Leaderofvalidationteem:方案制订日期：年月日Date:YearMonthDay目录ListofContent一.验证概述OVERVIEWOFVALIDATION二.验证组织机构及人员安排VALIDATIONORGANIZAGIONANDMEMBERS三.应用范围AREASOFAPPLICATION四.风险评估RISKEVALUATION五验证方案表格VALIDATIONMATRIX六清洁溶剂CLEANSINGAGENTS七.可接受标准的确定ACCEPTANCECRITERIA八.清洁验证取样CLEANINGVALIATIONANDSAMPLING九清洁验证的实施IMPLEMENTATIONOFCLEANINGVALIDATION十.偏差、变更DEVIATIONSANDCHANGES十一.再验证RE-VALIDATION一.验证概述OverviewofValidation1.验证目的根据GMP的要求，在口服固体制剂生产结束后，要对生产设备及操作间进行彻底清洁，以避免造成不同批号或不同品种产品之间的污染和交叉污染。根据各生产设备的《操作、清洁及维护保养》标准操作规程，进行风险分析，选出最坏情况产品。为了验证清洁方法的稳定性与可靠性，对所选的最坏产品进行三次清洁验证。每批产品生产结束后，对所有在生产中使用的生产设备及容器具进行清洁，清洁后取样检测化学残留及微生物残留，要求残留量低于设定的残留限度要求。AccordingtorequirementsofGMP,themanufacturingequipmentsandroomsmustbecompletelycleanedtoavoidcontaminationofdifferentbatchesofsameproductsorcross-contaminationofdifferentproductsaftermanufacturingoforalsoliddosage.TherearetwotypesofcleaningmethodbasedonSOPsofOperation/Cleaningandmaintenanceforindividualequipments:implementtheriskanalysisassessmenttochoosetheworstcaseproducts.Threeconsecutivecleaningvalidationwillbeconductedtovalidatethestabilityandreliabilityofcleaningmethod.Allequipmentsandutensilsusedinmanufacturingmustbecompletelycleanedonceeverybatchoftheworstcaseproductsarefinished,thensampletotestchemicalresidualandmicrobialresidual,therequirementisthelevelofresidualislessthanthelimitofresidual..二.验证组织机构及人员安排ValidationOrganizationandTeamMembers2.1制造部/ProductionDept.组织清洁验证方案及报告的起草；Preparethecleaningvalidationprotocol/report确定设备表面积、清洁方法、取样部位；Determinethesurfaceareaofequipments,cleaningmethodandsamplinglocations制定清洁操作规程；Establishcleaningprocedure按清洁操作规程清洁设备和容器具；Cleanequipmentsandutensilsaccordingtocleaningprocedure确保清洁记录填写完整；Makesurethecompletenessofcleaningrecords将完成的清洁验证文件提交给QA审查；SubmitthefinalizedcleaningdocumentationtoQAreview2.2质量保证部/QADept.QC审核清洁验证方案/报告；Reviewthecleaningvalidationprotocol/report制定清洁验证取样方法和检测方法；Establishsamplingmethodandanalyticalmethodofcleaningvalidation对清洁后设备、容器具进行取样和检测，报告检验结果；Sampleandtestcleanedequipmentsandutensils,thenreportthetestingresults.使用在校验有效期内的仪器设备进行检测。UsethoseinstrumentswithincalibrationexpireddateQA制定清洁验证计划及验证编号；EstablishcleaningvalidationplanandNo.负责组织审核清洁验证的方案/报告；Organizethereviewthecleaningvalidationprotocol/report组织清洁验证相关部门进行清洁验证方案的培训并记录；Organizethetrainingandrecordforcleaningvalidationprotocol负责验证实施过程的协调，保证验证项目实施进度；Coordinatetheactivitiesofcleaningvalidationtoensuretheperformance.验证实施中的监控检查；Supervisethevalidationactivities.保证经验证的参数符合预期的标准；Makesurevalidatedparametersmeetpre-determinedcriteria负责组织验证方案中改变控制、...
