药物安全评价研究中仪器设备的管理

Equipment Management in Drug Safety Evaluation and Research

实施药物非临床研究质量管理规范(GLP)的目的是保证新药毒理研究实验数据的真实、可靠,而实验室仪器设备的正常运行是达到这一目的的先决条件。本文参照国家相关药物非临床研究的规范,并结合本安全评价中心的实际情况,从人员的岗前培训、实验室管理规则、工作管理制度以及设备的日常管理与维护等方面来探讨药物安全评价中的仪器设备的管理,以期能够大大提高实验室仪器设备的管理水平。

The implementation of the Good laboratory practice of drug（GLP） aims to ensure that the New Drug Toxicology real and reliable experimental data,and the normal operation of the laboratory equipment is a prerequisite to achieve this purpose.In this paper,according to the national norms of Good laboratory practice of drug and the actual situation of our Safety Evaluation Center,we investigate the equipment management in drug safety evaluation and research from the pre-service training of the staff,rules of laboratory management,management system and equipment daily management and maintenance to expect to greatly improve the management level of the laboratory equipment.