工艺验证方案模板模板.doc

工艺验证方案模板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):pletiondate:验证完成日期:Validity:有效期:Index目录1. Purpose目的 52. Scope范围 53. Responsibility职责 5 AAAresponsibilitiesAAA的职责 5 XXXresponsibilitiesXXX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 14 Productspecification 14 DrugapprovalNo. 14 StandardFollowed: 14 RawMaterialsandAdjuvants原辅料情况 14 Processdescription: 16 ProcessRecipe工艺处方: 21 ListofProductionPlants生产车间一览 26 ListofProductionEquipment生产设备一览 29 ProcessFlowDiagram工艺流程图 33 CPPIdentificationCPP确认 34 ValidationPlan验证计划 498. Validationprerequisite验证先决条件 51 PersonalIdentification人员确认 51 ProcessDocumentationVerification生产文件确认 51 TrainingVerification培训确认 52 SystemandEquipmentInstrumentsCalibrationVerification系统和设备仪表校验确认 52 SystemandEquipmentInstrumentsCalibrationVerification生产相关验证状态确认 53 TestInstrumentsCalibrationVerification测试仪器和仪表校验确认 53 TestingMethodValidationVerification检验方法验证的确认 54 RawMaterialandExcipientVerification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 72 LiquidPreparation液体配制 72 CellResurrectionandPassage细胞复苏及传代 74 Harvestliquidtest收获液检测 81 ClarificationFiltrationEfficacyTest澄清过滤效果检测 83 UFConcentration1EfficacyTest超滤浓缩1效果检测 83 Ammoniumsulfateprecipitationefficacytest硫酸铵沉淀效果检测 85 Potassiumbromideextractionefficacytest溴化钾提取效果检测 86 Firstdensitygradientcentrifugationefficacytest一次密度梯度离心效果检测 87 Seconddensitygradientcentrifugationefficacytest二次密度梯度离心效果检