建立性能管理为核心的仪器设备质量管理新模式

目的 对仪器设备质量管理中存在的问题进行分析,探讨仪器设备质量管理的核心模式.方法 结合药品检测质量控制实验室仪器设备性能管理的实践,比较了几种性能验证的方式,并以中国食品药品检定研究院（NIFDC）药品质量控制实验室作为实例进行论证.结果与结论（1）仪器设备性能管理应是质量控制实验室仪器设备管理的核心. （2）性能管理通过仪器设备的检定、校准和核查来实现.（3） NIFDC药品质量控制实验室已经建立了符合世界卫生组织《药品质量控制实验室良好操作规范》（WHO GPCL）的仪器设备性能管理质量体系.

Establishment of a New Equipment Quality Management System with Performance Management as the Core

Objective To analyze the problems existing in equipment quality management and discuss the core mode of equipment quality management. Methods Several ways of performance verification were compared in combination with practice in equipment performance management in drug quality control laboratories. The Drug Quality Control Laboratory in National Institutes for Food and Drug Control was used as an example for validation. Results and Conclusion （1） Equipment performance management should be the core in equipment management of quality control laboratories. （2） Performance management could be fulfilled by verification, calibration and checking. （3） The Drug Quality Control Laboratory of NIFDC has established an equipment performance management system which is in compliance with the WHO 《good practices for pharmaceutical quality control laboratories》 （GPCL） .