制药企业实验室仪器综合管理

Comprehensive Management of Laboratory Instruments in Pharmaceutical Enterprises

制药企业实验仪器是实验室检测工作正常开展和取得实验数据准确可靠的重要保障。良好的仪器管理是保证实验数据的准确可靠的必要条件,该文从仪器申购、URS起草、选型、分类与影响性评估,验收,首次校准,建立管理档案,日检、期间核查、校准周期和维护,报废这一整个生命周期来探讨仪器的管理工作。

Experimental instruments in pharmaceutical enterprises are an important guarantee for the normal development of laboratory testing and the accuracy and reliability of experimental data.Good instrument management is a necessary condition to ensure the accuracy and reliability of experimental data.In this article,it discusses the management of the instrument from the aspects of instrument purchase,URS drafting,model selection,classification and impact assessment,acceptance,first calibration,establishment of management files,daily inspection,period verification,calibration cycle and maintenance,and scrapping the entire life cycle.