由药品检验的不合格案例分析维护药品标准的重要性

Discussion on Importance of Upholding Drug Specification from Cases of Substandard in Drug Inspection

目的通过分析近3年来上海市部分由于药品标准存在缺陷导致药品不合格的情况,寻找药品标准中存在的一些问题,为完善我国药品标准提供建议。方法对部分药品不合格的实例进行归类剖析。结果与结论国家药品标准制定与审批部门应建立快速有效的药品标准动态管理机制,对药品标准实施动态管理,监管部门和药品检验机构应加强沟通与协作,加强与企业的互动,企业作为标准的建立者和使用者应积极主动地采取措施完善药品标准。

Objective To find some problems in the drug specification by analyzing the reasons of substandard cases because of defects in these standards in Shanghai in three years recently.Methods Classifying and analyzing some cases of substandard drugs.Results and Conclusion To dynamic control,drug administration department should develop a fast reception-feedback system from the factory to modify their product＇s standard.Drug administration department should set up connected mechanism with the drug testing department to safeguard the standard when they find some problems.Pharmaceutical manufactories are responsible for the products and its standards to be more reasonable and effective.