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众所周知,药检所是执行国家对药品监督,管理的法定性专业机构。对药检部门而言,检验药品的法律依据就是药品的质量标准,但对生产企业来说.它就是控制产品质量的依据。因此,如何执行好药品质量标准,对药检部门和生产企业都是至关重要的,甚至会直接影响到人民用药的安全与有效。对国内药品,我们执行的是药品的三级标准,即《中国药典》,《卫生部药品标准》和各省、市、自治区地方药品标准。前二者是由药典会组织起草、修订并由卫生部颁发,而后者是由各省、市、自治区卫生厅、局审核批准的。在检验工作中遇到问题最多
As we all know, drug testing institutes are the statutory professional institutions that implement state supervision and administration of drugs. For the drug testing department, the legal basis for testing drugs is the quality standard of the drugs, but for the manufacturing enterprises, it is the basis for controlling the quality of the products. Therefore, how to implement good drug quality standards is crucial to the pharmaceutical inspection departments and manufacturing enterprises, and even directly affects the safety and effectiveness of people’s medication. For domestic medicines, we implement the three-level standards of medicines, namely, “Chinese Pharmacopoeia”, “Ministry of Health Drug Standards” and local drug standards of provinces, municipalities and autonomous regions. The former two are drafted, revised and issued by the Pharmacopoeia Commission and issued by the Ministry of Health, which is examined and approved by the health department and bureau of each province, municipality and autonomous region. In the inspection work encountered the most problems