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中华人民共和国药品管理法(双语)(3)

2014-02-26    来源:网络    【      美国外教 在线口语培训

(三)具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。
(3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.

第六条药品必须按照工艺规程进行生产,生产记录必须完整准确。
[Article 6] The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.

中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。
The preparation of Chinese medicines shall be in accordance with the "Pharmacopoeia of the People's Republic of China", or in accordance with the "Preparation Standards" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.

第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料,必须符合药用要求。
[Article 7] Raw materials and supplementary materials required for the production of drugs as well as containers and packing materials which come into direct contact with drugs shall meet standards required for pharmaceutical use.

第八条药品出厂前必须经过质量检验;不符合标准的,不得出厂。
[Article 8] Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory.



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