工艺验证方案模板

名称TitleProcessValidation(PV)ProtocolforXXXXXX工艺验证方案Doc.No.文件编号Page页码ProcessValidation(PV)ProtocolXXXXXX工艺验证方案Writtenby起草人Writtendate起草日期年月日Reviewedby审核人Revieweddate审核日期年月日Approvedby批准人Approveddate批准日期年月日Writtendepartment起草部门Effectivedate生效日期年月日Issuedby:颁发部门：[]Copynumber:拷贝号：[]Changerecord:Revisionnumber变更记载：DateofapprovalEffectivedate修订号批准日期生效日期Changereasonandgoal:变更原因及目的：Distributiondepartment:分发部门:所长办公室[]人力资源部[]后勤保卫部[]物资供应部[]工程服务部[]生产管理部[]质量保证部[]销售部[]仓储部[]疫苗一室[]疫苗二室[]疫苗三室[]疫苗五室[]疫苗六室[]生化制品室[]细胞因子室[]血清制品室[]实验动物室[]分包装室[]培养基室[]Verificationdepartment(department):验证科室（部门）：Verifycompletiondate:验证完成日期：Validity:有效期：名称TitleProcessValidation(PV)ProtocolforXXXXXX工艺验证方案Doc.No.文件编号Page页码Index目录1.Purpose目的.............................................................................................................52.Scope范围................................................................................................................53.Responsibility职责...................................................................................................53.1AAAresponsibilitiesAAA的职责....................................................................................53.2XXXresponsibilitiesXXX的职责....................................................................................64.RegulationandGuidance法规和指南....................................................................85.Abbreviations缩略语................................................................................................96.ProtocolDescription方案说明...............................................................................117.ProductAndProcessDescription产品和工艺描述..............................................147.1Productspecification.........................................................................................................147.2DrugapprovalNo..............................................................................................................147.3StandardFollowed:...........................................................................................................147.4RawMaterialsandAdjuvants原辅料情况.........................................................................147.5Processdescription:..........................................................................................................167.6ProcessRecipe工艺处方：..............................................................................................217.7ListofProductionPlants生产车间一览.............................................................................267.8ListofProductionEquipment生产设备一览....................................................................297.9ProcessFlowDiagram工艺流程图..................................................................................337.10CPPIdentificationCPP确认..........................................................................................347.11ValidationPlan验证计划...................................................................................................498.Validationprerequisite验证先决条件....................................................................518.1PersonalIdentification人员确认.......................................................................................518.2ProcessDocumentationVerification生产文件确认.........................................................518.3TrainingVerification培训确认..........................................................................................528.4SystemandEquipmentInstrumentsCalibrationVerification系统和设备仪表校验确认..528.5SystemandEquipmentInstrumentsCalibrationVerification生产相关验证状态确认.....538.6TestInstrumentsCalibrationVerification测试仪器和仪表校验确认.................................53名称TitleProcessValidation(PV)ProtocolforXXXXXX工艺验证方案Doc.No.文件编号Page页码8.7TestingMethodValidationVerification检验方法验证的确认.............................................548.8RawMaterialandExcipientVerification原辅料确认........................................................549.SamplingPlanandEvaluationCriteria取样计划及评估标准...............................5610.SampleCodingMethod样品编码原则...................................................................7011.ProcessValidationTestExecution工艺验证执行...............................................7211.1LiquidPreparation液体配制.............................................................................................7211.2CellResurrectionandPassage细胞复苏及传代..............................................................7411.3Harvestliquidtest收获液检测..........................................................................................8111.4ClarificationFiltrationEfficacyTest澄清过滤效果检测....................................................8311.5UFConcentration1EfficacyTest超滤浓缩1效果检测....................................................8311.6Ammoniumsulfateprecipitationefficacytest硫酸铵沉淀效果检测...............................8411.7Potassiumbromideextractionefficacytest溴化钾提取效果检测....................................8511.8Firstdensitygradientcentrifugationefficacytest一次密度梯度离心效果检测................8611.9Seconddensitygradientcentri