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深挖风险隐患、封堵监管漏洞 武汉开展食品药品百日执法大检查

2017-08-27 09:15:50   中国青年网

人民网武汉8月27日电 (金雨蒙)武汉市食品药品监督管理局在全市开展百日执法大检查活动,深挖食品药品安全领域风险隐患,强化食品药品安全风险隐患排查整治,切实堵塞监管漏洞。大检查已于本月上旬启动,将持续至10月底。

对食品安全开展综合检查

针对食品生产经营企业,以检查企业生产经营条件、制定并执行食品安全制度、履行食品安全主体责任为重点,全面深入对企业从原辅料采购到产品生产流通全链条存在的食品隐患和问题进行执法检查。

在开展执法检查的同时,检查组还将对各区食品安全监管重点工作推进情况进行检查,包括风险分级监管、省局市局开展的食品安全专项整治、建设放心肉菜示范超市、明厨亮灶、重点食品生产企业建立食品安全追溯体系建设情况等。

对药品生产企业实行全覆盖检查

针对药品生产企业,实行监督检查全覆盖。无菌药品生产企业、特殊药品及其复方制剂生产企业,新开办或近三年有新上市品种生产企业,规模以上药品生产企业,成为此轮检查重点对象。

检查内容主要包括:企业是否存在不按规定投料生产,未按规定对原辅料、成品进行检验,伪造或篡改批生产记录和批检验记录等。

对药品流通企业展开全类型检查

对于批发企业,严查出租出借经营、挂靠经营、超范围经营、走票、过票或向非法单位供货、不按照要求的温湿度储运药品等违法违规行为;对于药店,严查超范围超方式经营药品、非法渠道购进药品、不按照要求的温湿度储运药品、执业药师不在岗审核处方、违规处方药销售等。对于诊所,严查非法渠道购进药品、不按照要求的温湿度储运药品、未建立药品购进记录、购进药品,未建立并执行进货检查验收制度、使用过期药品等。

对医疗器械开展全链条检查

针对医疗器械安全,执法人员将开展全链条检查。在生产企业,对厂房与设施是否符合生产要求,是否按照技术要求的工艺流程生产,采购信息是否可追溯,对采购物品是否进行检验或验证等进行重点检查。在经营企业,重点检查经营条件是否发生变化,是否存在擅自变更经营场所等行为;查验经营企业供货商、客户及产品的相关资质,查看产品合格证明文件及有效期等相关信息。在使用单位,检查组将围绕购进渠道、购进使用医疗器械的合法性,植入性和介入类医疗器械的可追溯性,以及仓库设置进行重点检查。

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