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甘肃省开展药品生产质量安全专项整治行动

2018-06-21 09:42 来源: 甘肃日报
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针对药品生产和医疗机构制剂质量安全方面的突出问题和风险隐患,日前,省食药监局制定工作方案,围绕全省药品重点领域、关键环节、高风险企业和品种实施专项整治,严厉打击违法违规行为,倒逼企业落实药品质量安全主体责任。

此次专项整治范围涵盖中药制剂、多组分生化制剂和注射剂、生物制品、血液制品、胶类产品、中药饮片、特殊药品等高风险品种和医疗机构制剂配制单位。检查内容覆盖原辅料管理、生产工艺执行、生产过程管理等全过程,以及对中药提取和提取物管理、药品委托生产管理相关规定的落实情况等。对高风险药品生产企业依据药品生产质量管理规范及有关附录,对医疗机构制剂依据医疗机构制剂配制质量管理规范,开展现场检查,分析、评估发现的问题,制定切实可行的风险防控措施,督导企业建立并落实风险清单,及时消除药品生产质量安全隐患。同时,将专项整治与检验、监测、稽查结合起来,及时管控问题药品。原辅料未经检验检疫投料生产的,产品未按标准经检验放行上市的,一律责成停产,并召回已上市销售的产品;外购未经备案的中药提取物投料生产的,外购原辅料的生产和质量管理失控的,原辅料检验不合格投料生产的,未按法定处方标准工艺投料生产的、擅自改变处方工艺生产和擅自委托生产加工的,依法严厉查处,收回《药品GMP证书》。情节严重的吊销《药品生产许可证》,涉嫌犯罪的,移交司法机关追究刑事责任。(记者 宜秀萍)

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