压缩空气系统运行确认方案.docx

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1、Operationconfirmationschemeofcompressedairsystem压缩空气系统运行确认方案SystemNo.文件编号：KYJ-OQ-ALE65A-H01Seriesno.系列号：3CD01047批准页Approvalpage1、起草人签字的含义：你的签字表示你所制订的文件符合现有设计标准并且充分反映该系统的验证任务和可交付使用的必要条件。Draftsmensignmeaning:yousaidyouthesignatureofthestipulateddocumentsinaccordancewithcurrentdesignstandardsandfullyre

2、flectthesystemvalidationtaskanddeliverablenecessarycondition.方案制订部门Schemedesigningdepartment制订人implementer签字Sign日期Date2、审核人签字的含义：你的签字表明你已经审核了这份文件，确认此文件能准确全面地反映该系统的验证任务和可交付使用的必要条件。Reviewthemeaningofsignature:yoursignaturethatyouhavereviewthefiles,makesurethatthefilecanaccuratelyreflectthesystemvalida

3、tiontaskanddeliverablenecessarycondition.方案审核部门Schemedesigningdepartment审核人Reviewpeople签字Sign日期Sign3、批准人签字的含义：你的签字表明这份文件符合我公司验证主计划的标准；并且文件及其所含盖的信息符合现行的GMP,同意按此方案实施验证。Approvedsignaturemeaning:yoursignatureshowsthatthedocumentsinaccordancewithmycompanyvalidationmasterplanstandards;Andthedocumentsandin

4、formationcoveredwithcurrentGMP,agreestotheplanofvalidation9方案批准部门Schemedesigningdepartment批准人approver签字Sign日期Date目录页码DirectoryPage1目的4Aim455577788999999.10.10.121.13.13.13.13.14.14.14114.142范围3职责Duty4法规和指南Regulationandguide5缩略语6风险因素分析Riskfactoranalysis7设备OQ前回顾EquipmentbeforeOQreview8系统描述Systemdescri

5、ption9文件管理规范Filemanagementstandard10人员培训Personneltraining11运行确认测试Operationalqualificationtest12检测设备确认Testingequipmentconfirmation13仪器、仪表的校验Instrumentsofthecheck14运行确认OperationalQualification15验证的规定Theprovisionsoftherevalidation16测试报告目录Testreportdirectory1目的Aim1.1 检查该设备的文件资料齐全且符合GMP要求；Checkthedeviced

6、ocumentationiscompleteandinaccordancewithGMPrequirements.1.2 确认该系统设备的各种仪器、仪表经过校正或校验且合格；Confirmthesystemequipmentvariousinstrumentsaftercorrectionorcheckandqualified.1.3 确认该系统设备的性能符合生产及GMP要求。ToconfirmthatthesystemperformancewithproductionandGMPrequirements.2范围Scope本方案适用于本公司制剂一车间的压缩空气系统的运行确认，其内容依据本公司所

7、要求指标，定义出测试步骤、文件、参考资料及合格标准。ThisschemeisapplicabletothethirdphaseofinsulininjectionworkshopaircompressoroperationalqualificationJtscontentaccordingtothecompanyrequiredindex,defineteststepfilereferencematerialandqualifiedstandard.3职责Duty3.1 使用部门Userdepartment3.1.1 配合设备部门完成空气压缩运行确认，检查验证项目是否完成Cooperatewi

8、thfacilitydepartmentstoaccomplishtheaircompressoroperationqualificationinspectionvalidationprogramisnotcomplete.3.1.2 执行验证方案，根据需要提供测试数据，供有关部门审查；Implementtestplan,accordingtotheneedfortestdata,therelevantdepartmentsforreview.3.1.3 将数据收集到报告中，并上报批准；Thedatacollectiontoreport,andreporttheapproved3.1.4 核对

9、设备关键参数，提供测试数据供有关部门审查；Thedatacollectiontoreport,andreporttheapproved.3.1.5 建立预防性维修制度。Establishpreventivemaintenancesystem.3.2 设备部EquipmentDepartment3.2.1 制订验证方案和总结报告；Makeverificationplanandsummaryreport3.2.2 组织实施验证；Organizationtoperformverification.3.2.3 协调有关部门；Coordinaterelevantdepartments.3.2.4 核实所

10、有的测试已完成；Verifyallthetesthasbeencompleted.3.2.5 核对报告所需的测试项目是否完成可上报批准；Checkthereportrequiredtestprojectshaveachievedapprovalreport.3.2.6 配合验证的实施工作；Withtheimplementationoftheverificationwork.3.2.7 完成相关的检测工作，出据检验报告；Completetherelevanttestshallissueinspectionreport.3.2.8 领导审阅验证方案、数据和最后报告。Leadershipreview

11、thallilibrarydatavalidationprotocolsandfinalreport.3.3 QAQualityAssurance3.3.1 支持验证方案；Supportrevalidationscheme.332审阅验证方案的格式；Reviewandverifytheformatofthescheme.3.3.3 为书写方案的人员提供指南，为执行方案提供时间表；Forwritingtheschemeprovideguidelines,fortheimplementationofthesolutiontoprovideschedule.334对相关人员提供的完成验证工作的步骤提

12、供审阅、帮助和支持，以在实行验证过程中对取样和操作设备和设备体系提供帮助；Providetherelevantpersonneltocompletevalidationstepsreviewprovidehelpandsupporttotheimplementationoftheverificationprocesstosamplingandoperatingequipmentandequipmentsystemtoprovidehelp.3.3.5 审阅验证方案和检验必要的SOP,完成必需的和可提供的培训；Throughverificationschemeandtestthenecessar

13、ySOP,completethenecessaryandprovidetraining3.3.6 维护全部受控的法规符合文件，包括验证方案；Maintainallcontrolledcompliancedocumentation,includingrevalidationscheme.3.3.7 审查和批准验证方案和验证报告。Reviewandapprovalandverificationschemeandvalidationreportagain.3.4 验证项目小组成员及职责Verifytheprojectteammembersandresponsibility成员Member姓名Name

14、部门Part职责Duty组长Headman验证负责人，发起、组织、实施、协调本次确认，并对本方案进行审核。Validation,thepersoninchargeoftheimplementationoftheorganizedcoordinationtheconfirmation,thisplanandaudit.组员Groupmembers参与运行确认方案的制定；运行确认实施及报告整理、收集、上交。Participateintheformulationofoperationalqualificationplan;Operationalqualificationimplementationandreportincollecting.参与运行确认方案的制定；运行确认实施及报告整理。Participateintheformulationofoperationalqualificationplan;Implementationandoperationalqualificationreports.参与运行确认方案的制定；运行确认实施及报告