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第一章 总 则 第一条 为加强药品经营质量的管理,规范GSP的认证工作,根据《中华人民共和国药品管理法》及国家有关规定,制定本办法。 第二条 GSP认证是国家对药品经营企业药品经营质量管理进行监督检查的一种手段,是对药品经营企业实施GSP情况的检查认可和监督管理的过程。
Chapter I General Provisions Article 1 These Measures are formulated in accordance with the “People’s Republic of China Drug Administration Law” and the relevant regulations of the State in order to strengthen the management of drug operation quality and standardize the GSP certification work. Article 2 GSP certification is a means by which the state supervises and inspects the pharmaceutical business quality management of pharmaceutical companies, and it is a process of inspection, approval and supervision of the implementation of GSP by pharmaceutical trading enterprises.