面向药品质控实验室认证的仪器设备采购管理实践

Equipment purchase management for medicines quality control laboratory certification

介绍了WHO药品质控实验室认证对仪器设备管理的要求,将质控实验室认证中的4Q验证(设计验证、安装验证、操作验证和性能验证)应用于实验室仪器设备采购管理实践,总结出一套基于4Q验证的仪器设备采购管理模式,规范了仪器设备采购管理程序。此管理模式的建立为国内食品药品检验检测机构通过WHO药品质控实验室认证创造了条件。

The requirements of WHO medicines control laboratory certification（GPCL） are introduced for the equipment purchase management. 4Q certification, including Design qualification, Installation qualification, Operational qualification and Performance qualification, is applied to purchase management of laboratory equipment. A set of 4Q certification-based equipment purchase management mode is put forward to standardize the process, which facilitates the food and drug inspection institute in China to pass the certification of WHO＇s medicines control laboratory.