药品检测标准管理应用系统的建设

Discussion on the construction of pharmaceutical standards management application system

目的:通过介绍我院药品注册标准的管理流程和现阶段存在的问题以及对策,为今后药品标准管理的方向提供参考。方法:以我院近几年的标准管理手段做参考,从标准管理的流程、2017年药品注册标准数目概况及品类占比等方面分析我院药品注册标准管理现状及存在的问题。结果与结论:在药品注册标准管理的过程中,仍然存在着人工管理误差大、耗时长、效率低等问题,使用者也存在标准查询不到、标准号与实际内容对应不上、不能被下载使用等问题。未来标准管理应朝着信息共享、提高标准准入门槛的大方向发展。

Objective : To provide reference for pharmaceutical standards management by means of introducing management process and existing issues of pharmaceutical registrationstandards in NIFDC. Methods : Taking pharmaceutical standards management methods of NIFDC as reference, the management patterns of pharmaceutical standards, the number of registration standards in 2017 and proportion of varieties of standards were analyzed and discussed. Results and Conclusion : There are still issues existed such as out-dated manual working, time-consuming, low-efficiency and so on through the whole management procedure. As for users, standards can′t be searched and can′t be downloaded are intractable issues. In the future, information sharing and high criteria of pharmaceutical standards should be prospective development direction.