由世界卫生组织开展的药物生产资格预认证项目是一个有利于提高国内制药企业GMP水平的项目,也是国内制药企业参与国际招标,走向国际的一条优选之路。论述药物生产资格预认证项目对国内制药企业发展的积极作用,并浅谈在实践该项目过程中的经验和体会,为国内制药企业参加该项目提供参考。 The project of prequalification of drug production by WHO is a project conducive to raising the level of GMP in domestic pharmaceutical companies and a preferred way for domestic pharmaceutical companies to participate in international bidding and go international. Discusses the active role of prequalification project of pharmaceutical production qualification in the development of domestic pharmaceutical enterprises, and briefly discusses the experience and experience in the process of implementing the project, providing reference for the domestic pharmaceutical enterprises to participate in the project.