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四川高原明珠制药涉多项违规被查 防鼠措施不当

2017-06-12 17:33:41   四川在线

四川在线消息(记者 周伟)将复方板蓝根颗粒生产批量由5万袋变更为48万袋、中药材常温库二山楂外包装可见有老鼠粪便、存在删除图谱现象且未记录原因……6月12日,记者从国家食药监管总局官方网站获悉,在该网“飞行检查”一栏,国家食药监管总局日前发布了《对四川高原明珠制药有限公司跟踪检查通报》(以下简称《通报》),要求四川省食药监局收回该企业相关《药品GMP证书》,监督企业召回相关产品,并对该企业违法违规行为开展立案调查。

《通报》显示,四川高原明珠制药有限公司存记录造假和删除修改数据等数据可靠性等5个方面的问题。如,现场检查发现企业正在编造批量为48万袋的复方板蓝根颗粒(15g)工艺验证方案及报告;擅自修改计算机系统时间。存在删除图谱现象,且未记录原因。该企业复方板蓝根颗粒生产批量由5万袋变更为48万袋,提取设备变更前使用一个提取罐,目前使用四个提取罐生产,未进行变更控制,且未对变更的批量进行风险评估和工艺验证。现场检查时固体制剂车间复方板蓝根颗粒制粒(批号161203)批生产指令为:计划批量30.6万袋,与工艺规程规定的批量48万袋不符,未进行相关的变更管理。

《通报》认为该企业物料管理和清场不规范。防虫防鼠害措施不当,中药材常温库二山楂外包装可见有老鼠粪便;中药材常温库面积偏小,与生产规模不适应,如不能满足最大批量大青叶(批号161003,批量72000kg)的存放。无通风设施;清场不彻底,不能有效防止污染和交叉污染:前处理提取车间投料口和提取罐、渗漉罐的软连接(棉布)上布满灰尘。

对此,国家食品药品监督管理总局认为四川高原明珠制药有限公司上述行为已违反《中华人民共和国药品管理法》及药品GMP相关规定,国家食品药品监督管理总局要求四川省食品药品监督管理局收回该企业相关《药品GMP证书》,监督企业召回相关产品,对该企业违法违规行为开展立案调查。

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