无菌层流车ioq实用模板

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1、实用标准文案安装确认和运行确认方案INSTALLATIONANDOPERATIONALQUALIFICATIONPROTOCOL设备名称EquipmentName层流车2#Laminarcar2#设备编码EquipmentID生产线Productionline建筑楼BuildingNo精彩文档实用标准文案Preparedby起草Title职务Name姓名Signature签字Date日期生产ProductionReviewedby审核Title职务Name姓名Signature签字Date日期工程Engineering生产Manufact

2、uring验证Validation质量QAApprovedby批准Title职务Name姓名Signature签字Date日期质量管理负责人QP精彩文档实用标准文案修订历史纪录RevisionHistoryRevision版本RevisionDate修订日期ReasonforRevision/ChangeRequest修订/更改要求的原因RevisedBy修订人01精彩文档实用标准文案TABLEOFCONTENTS目录1.目的OBJECTIVE62.确认范围QUALIFICATIONSCOPE63.系统描述SYSTEMDESCRIPTIO

3、N64.部门职责DEPARTMENTALRESPONSIBILITIES74.1验证VALIDATION74.2工程ENGINEERING74.3生产PRODUCTION74.4质量保证QUALITYASSURANCES(QA)74.5质量管理负责人QUALIFIEDPERSON（QP）85.接受标准ACCEPTANCECRITERIA86.总结报告SUMMARYREPORTRESULTS87.实施和文件要求IMPLEMENTANDDOCUMENTATIONREQUIREMENTS88.培训确认/签名表PRE-QUALIFICATIONT

4、RAININGVERIFICATION/SIGNATURELOG99.检测仪器校准情况确认TESTINSTRUMENTCALIBRATIONVERIFICATION1010.安装确认INSTALLATIONQUALIFICATION1010.1标牌及各部件安装确认NAMEPLATEDATAANDINSTALLATIONQUALIFICATION1110.2推荐润滑油确认RECOMMENDEDLUBRICANTSVERIFICATION1310.3预防性维护程序确认PREVENTATIVEMAINTENANCEPROGRAMVERIFICA

5、TION1410.4设备/系统文件SYSTEMDOCUMENTATION1511.OQ许可审批APPROVALTOPROCEEDWITHOQ1612.运行确认OPERATIONALQUALIFICATION1712.1标准操作程序确认STANDARDOPERATINGPROCEDUREVERIFICATION1712.2培训确认TRAININGVERIFICATION1812.3关键仪器校准确认CRITICALINSTRUMENTATIONCALIBRATIONVERIFICATION1912.4系统功能测试SYSTEMFUNCTIONA

6、LTESTING2012.4.1功能测试-UPS续航能力确认FUNCTIONALTESTING–UPSENDURANCEABILITYCONFIRMATION2112.4.2功能测试-层流风机无级调速确认FUNCTIONALTESTING–CHECKOFLAMINARFLOWFANSPEEDREGULATION2212.4.3功能测试-层流风速检测FUNCTIONALTESTING–LAMINARAIRFLOWVELOCITYTEST2312.4.4功能测试--压差检查FUNCTIONALTESTING–CHECKOFDIFFERENTI

7、ALPRESSURE2512.4.5功能测试-层流高效过滤器完整性测试FUNCTIONALTESTING–LAMINARFLOWHIGHEFFICIENCYFILTERINTEGRITYTEST2612.4.6功能测试-静态层流流型测试FUNCTIONALTESTING–STATICLAMINARFLOWPATTERNTEST2712.4.7功能测试-静态尘埃粒子测试FUNCTIONALTESTING–STATICSTATEPARTICLESTEST28精彩文档实用标准文案13.确认接受标准总结QUALIFICATIONACCEPTANC

8、ECRITERIASUMMARY2914.方案修改PROTOCOLMODIFICATIONS3015.方案偏差PROTOCOLDEVIATIONS3016.参考文件REFERENCES3017