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食药监总局”晒”质量公告 99批次药品不符标准规定
发布时间: 2014-09-01 - 标签: , , - 浏览 2,446 次

昨日本报记者从国家食品药品监督管理总局的官网获悉,其“晒”出了最新的药品质量公告,披露了99批次药品经检验不符合标准规定,但公告称总体抽检质量良好。

本次抽检分别从药品生产、经营和使用环节抽取了格列美脲片、小儿化痰止咳颗粒、康尔心胶囊、地塞米松磷酸钠注射液、小活络丸、三七伤药片、乙型肝炎表面抗原诊断试剂、亚硫酸氢钠等148个品种共13461批次产品;其中,国家基本药物品种56个,共4713批次。

公告显示,本次抽检不符合标准规定药品的不合格项目主要有:含量测定、鉴别、性状,以及检查项中的装量差异、重量差异、含量均匀度、可见异物、溶出度、溶散时限、崩解时限、水分、pH值、有关物质、溶液的澄清度与颜色、细菌数、细菌内毒素、微生物限度等。相关省(区、市)食品药品监督管理部门已对本次抽检结果为不符合标准规定的药品采取了必要的控制措施,对有关生产企业和被抽样单位依法进行了查处。

公告指出,本次被抽检产品的总体质量状况良好,但也暴露出个别药品生产企业在原辅料购进、生产过程控制、无菌保障水平等方面存在一定缺陷,部分企业和单位在药品运输、贮藏等条件保障方面还存在一定问题。食药监总局要求相关企业和单位认真检查,切实消除隐患。

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