固体车间清洁验证方案

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1、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-1-目录ListofContent一.验证

2、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IMPLEMENTATIONOFCLEANINGVALID

3、ATION十.偏差、变更DEVIATIONSANDCHANGES十一.再验证RE-VALIDATION第41页共41页一.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

4、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-contaminationofdifferentproductsaftermanufacturingoforalsolidd

5、osage.TherearetwotypesofcleaningmethodbasedonSOPsofOperation/Cleaningandmaintenanceforindividualequipments:implementtheriskanalysisassessmenttochoosetheworstcaseproducts.Threeconsecutivecleaningvalidationwillbeconductedtovalidatethestabilityandreliability

6、ofcleaningmethod.Allequipmentsandutensilsusedinmanufacturingmustbecompletelycleanedonceeverybatchoftheworstcaseproductsarefinished,thensampletotestchemicalresidualandmicrobialresidual,therequirementisthelevelofresidualislessthanthelimitofresidual..二.验证组织机

7、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

8、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；Reviewt