美国药典委员会组织架构与标准制修订程序的概述及启示

Overview and Inspiration of the USP Organization Structure and Procedure of USP-NF monograph development

药典机构的组织架构和工作程序是做好药品标准工作的基石与保障。组织架构和工作程序的科学性、合理性,直接影响药品标准工作的质量和效率。本文对美国药典委员会的组织架构以及标准制修订程序进行总结,深入分析其制度及程序的合理性,为以后借鉴学习其先进经验奠定基础。

Good compendial standards are based on the organization structure and work procedure of Pharmacopoeia institutions. The scientificity and rationality of organization structure and work procedure would directly affect the quality and efficiency of compendial standards development. The USP organization structure and procedure of USP- NF monograph development are summarized, and the rationality of USP organization and procedure is analyzed deeply to lay the foundation for learning the advanced experience.