基层药检所在确认药品标准时遇到的问题探讨  

On Existing Problems during the Process of Drug Standard Confirmation the Grassroots Drug Control Institute

作　　者：李亚男 

机构地区：[1]辽宁省丹东市药品检验检测中心,丹东118000

出　　处：《中国药事》2016年第10期957-959,共3页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨基层药检所在使用药品说明书确认药品标准时遇到的问题及其对药品检验工作的影响。方法:将工作中发现的由药品说明书执行标准项目不规范引起的问题进行分析。结果:药品说明书中执行标准项目存在较多问题,例如药品标准的错误使用,版本更新不及时,对勘误、更正、修订及补充申请批件等相关内容缺少准确表述等,这些问题增加了确认药品标准的难度。结论:规范药品说明书的执行标准项目可以有效简化标准确认过程,确保正确使用标准,提高药检所的工作效率。Objective： To explore the problems that occur when the grassroots drug control institute try to confirm the drug standard with the drug instruction. Methods： The problems caused by the inaccurate drug instruction were analyzed and discussed. Results： There are many problems in the implementation of standard in drug instruction, such as inaccurate drug standards, delayed version updates, lack of accurate representation for corrections, amendments, revision and supplements. These problems make the process of the drug standard confirmation more complicated. Conclusion： It is necessary to standardize the drug implementation standards to simplify the process of standard confirmation, so as to guarantee the proper use of standards and raise the efficiency of the drug control institute.

关 键 词：药品检验 药品标准 药品说明书 执行标准 

分 类 号：R926[医药卫生—药学] R954