请问药品出厂必须全检吗?出自哪里呢?新版GMP里没找到。就是说哪里规定的成品必须全检。

2025-03-14 23:11:17
推荐回答(1个)
回答1:

《药品管理法》第八条规定,开办药品生产企业必须具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备。第十二条规定:“药品生产企业必须对其生产的药品进行质量检验;不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的,不得出厂。”从以上条款的立法原意理解,作为一项有效的药品质量控制手段,药品出厂前的质量检验至关重要,是药品生产的必要环节,任何生产企业都有义务严格执行,不得遗漏检验项目,不得擅自变更检验标准,否则就是违法行为。

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