2013-2015年湖北省药品质量监督抽验结果分析

发布时间：2018-08-17 13:45

【摘要】：目的:评价湖北省药品抽验质量情况,为监管部门与药品生产企业提供参考。方法:收集汇总湖北省食品药品监督检验研究院2013-2015年省计划抽验药品检验结果,以现行标准对总体质量状况及不合格样品情况进行统计分析。结果与结论:2013-2015年共完成省计划抽验药品检验7 721批,发现不合格样品333批,占4.3%。不合格产品主要出自经营企业(不合格率为2.8%~9.0%)和医疗机构(不合格率为5.2%~11.7%);从品种看,中药材不合格率最高(12.1%~37.4%)、不合格项目(含量测定、补充检验项目、性状、二氧化硫残留量及灰分等项目)种类最多,药物制剂的质量则相对稳定,不合格项目分布与品种和剂型有关。宏观层面存在现有标准水平参差不齐、抽验资源分配欠合理、行业整体水平较低等问题。建议监管部门整顿药品标准,合理规划抽验工作,加强生产企业源头治理。
[Abstract]:Objective: to evaluate the quality of drug sampling in Hubei Province and to provide reference for supervision department and drug manufacturing enterprise. Methods: to collect and collect the results of drug inspection in the provincial plan of Hubei Food and Drug Supervision and Inspection Institute 2013-2015, and analyze the total quality and unqualified samples according to the current standard. Results and conclusion A total of 7,721 batches of drugs were tested in the provincial plan in 2013-2015, 333 batches of unqualified samples were found, accounting for 4.3 batches. The unqualified products mainly come from the enterprises (2.89.0%) and the medical institutions (5.2or 11.7%), the unqualified rate of Chinese medicinal materials is the highest (12.1% 37.4%), and the unqualified items (content determination, supplementary inspection items, traits) are the highest. The content of sulfur dioxide and ash is the most, the quality of drug preparation is relatively stable, and the distribution of unqualified items is related to the variety and dosage form. There are some problems in macroscopic level, such as uneven standard level, unreasonable allocation of sampling resources and low level of industry as a whole. Regulatory authorities to rectify drug standards, reasonable planning sampling work, strengthen the source management of production enterprises.
【作者单位】：湖北省食品药品监督检验研究院;
【分类号】：R95

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