工艺验证方案模板.doc

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1、word格式文档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：DateofapprovalEffective

2、date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）：Verify completiondate:验证完成日期：

3、Validity:有效期：专业整理word格式文档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147.1Productspecification147.2

4、DrugapprovalNo.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.Va

5、lidationprerequisite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53专业整理wor

6、d格式文档8.6TestInstrumentsCalibrationVerification测试仪器和仪表校验确认538.7TestingMethodValidationVerification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7211.1

7、LiquidPreparation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8511.7Potassiumbromideextractioneffica

8、cytest溴化钾提取效果检测8611.8Firstdensitygradientcentrifugationefficacytest一次密度梯度离心效果检测8711.9Seco