摘 要 目的：为有效控制药品流通过程中的质量风险，确保药品采购渠道合法合规，保证药品质量。方法：通过首营品种案例分析，结合在首营品种申报审核时存在的问题，论述首营品种及首营企业质量审核的重要性。结果与结论：医药经营企业在引进药品时，推进做好首次经营品种及首营企业的质量审核工作，有效控制经营风险，确保人民用药安全有效。

    关键词 首营企业 首营品种 质量审核 风险控制

    中图分类号：F715.3 文献标识码：C 文章编号：1006-1533(2013)11-0039-03

    Practice and exploration of the audit of

    the first commercial varieties in pharmaceutical enterprises

    YUAN Qiong

    (Shanghai Pharmaceutical Distribution Co.， Ltd.， Shanghai 200002， China)

    ABSTRACT Objective： To effectively control the quality risk in circulation to ensure legal compliance of drug procurement channels and the quality of medicines. Methods： The importance of the species and the first venture of a quality audit is discussed by analysis of the case of the first varieties of marketing drugs and the problem existing in its reporting audit. Results & Conclusion： Pharmaceutical enterprises should promote the audit work of quality for both the first marketing varieties and the first marketing enterprise so as to effectively control the operational risks and to ensure the safe and effective medication when introducing drugs. ......