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广东惠州市三药企被要求限期整改 原因各异

2017-08-09 15:40:38   中国经济网

中国经济网北京8月9日讯 (记者 吴晓薇)据广东省食品药品监督管理局消息,惠州市食品药品监督管理局组织的监督检查中发现,惠州市健民医药连锁有限公司、惠州市三九大药房有限公司、惠州市百姓大药房医药连锁有限公司3家药品经营企业不符合《药品经营质量管理规范》规定,市局依据《药品医疗器械飞行检查办法》(国家食品药品监督管理总局令第14号)、《药品经营质量管理规范认证管理办法》等规定,依法责令其在整改通知下发之日起1个月内完成整改,并申请复检。

不合格情况为:惠州市健民医药连锁有限公司企业未在质量管理体系关键要素发生重大变化时,组织开展内审。新规实施后未开展内审;企业开展的培训无考核内容;企业直接接触药品岗位人员的健康体检已过期。

惠州市三九大药房有限公司从事质量管理、验收工作的人员未履行在职在岗职责。企业质管部人员业务不熟,操作计算机系统等业务工作需要方舟药业的质管部人员帮忙; 质量管理部门未履行指导设定计算机系统操作权限审核的职责,计算机质量管理系统授权未按要求;培训内容不全面,缺少“三统一”方面的培训,导致个别门店不熟悉操作计算机系统。惠州市三九大药房有限公司康吉分店、惠州市三九大药房有限公司新寮分店的从业人员操作门店计算机管理系统不熟练。

惠州市百姓大药房医药连锁有限公司企业未按照温度要求储存药品。如企业2016年9月8日、2016年9月9日出现温度未达到阴凉库标准的现象,此期间需阴凉储存的药品放置在此;养护人员未对库房温湿度进行有效的监测、调控。如企业2016年9月8日、2016年9月9日均出现温度连续超标现象。每次超标现象持续时间超过半个小时; 企业经营冷藏、冷冻药品未配备冷藏车;储存药品未按照要求采取防鼠措施。挡鼠板未设置在仓库的出入口。

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