工艺验证方案模板.pdf

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1、ProcessValidation(PV)ProtocolforXXX名称TitleXXX工艺验证方案Doc.No.Page文件编号页码ProcessValidation(PV)ProtocolXXXXXX工艺验证方案WrittenbyWrittendate年月日起草人起草日期ReviewedbyRevieweddate年月日审核人审核日期ApprovedbyApproveddate年月日批准人批准日期WrittenEffectivedatedepartment年月日生效日期起草部门Issuedby:Changerecord:RevisionnumberChangereason颁发

2、部门：[]变更记载：DateofapprovalEffectivedateandgoal:Copynumber:修订号批准日期生效日期变更原因及目的：拷贝号：[]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）：Verifycomple

3、tiondate:验证完成日期：Validity:有效期：ProcessValidation(PV)ProtocolforXXX名称TitleXXX工艺验证方案Doc.No.Page文件编号页码Index目录1.Purpose目的.............................................................................................................52.Scope范围............................................................

4、....................................................53.Responsibility职责...................................................................................................53.1AAAresponsibilitiesAAA的职责....................................................................................53.2XXXresp

5、onsibilitiesXXX的职责....................................................................................64.RegulationandGuidance法规和指南....................................................................85.Abbreviations缩略语............................................................................

6、....................96.ProtocolDescription方案说明...............................................................................117.ProductAndProcessDescription产品和工艺描述..............................................147.1Productspecification...........................................................

7、..............................................147.2DrugapprovalNo..............................................................................................................147.3StandardFollowed:.......................................