Annex 2(QC) 世界卫生组织药品微生物实验室管理规范.pdf

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1、WHO技术指南报告No.961,2011,annex2WHO药品微生物实验室管理规范©WorldHealthOrganization世界卫生组织WHOTechnicalReportSeries,No.961,2011世界卫生组织技术报告系列，编号961，2011年Annex2附录2WHOgoodpracticesforpharmaceuticalmicrobiologylaboratories世界卫生组织药品微生物实验室管理规范目录Background背景.................................................................

2、............................................................2Introductionandscopeofdocument文件介绍和范围...................................................................2Glossary术语表......................................................................................................................

3、.........31.Personnel人员............................................................................................................................52.Environment环境........................................................................................................................62.1Premises

4、房屋...........................................................................................................................62.3Cleaning,disinfectionandhygiene清洁、消毒和卫生...............................................................82.4Sterilitytestfacilities无菌试验设施...............................

5、.............................................................83.Validationoftestmethods检验方法的验证..............................................................................104.Equipment设备............................................................................................................

6、.............104.1Maintenanceofequipment设备维护.......................................................................................114.2Qualification验证....................................................................................................................114.3Calibration,performancev

7、erificationandmonitoringofuse校准、性能确认和使用的监控......114.3.3Temperaturemeasurementdevices温度测量装置.....................................................................114.3.4Incubators,water-bathsandovens培养箱、水浴和烘箱..........................