对我国GSP标准与世界卫生组织推荐的GDP标准的比较与分析

Comparison and Analysis of Chinese Current GSP Guidelines and WHO Recommended GDP Guidelines

目的对我国现行GSP标准与世界卫生组织推荐的GDP标准进行比较和分析,找出值得我们借鉴的方面。方法从编写结构、适用范围、管理过程、硬件设施、售后跟踪等方面详细比较和分析了GSP标准和GDP标准。结果与结论在编写思路和管理重点上两个标准是相似的,但GDP标准在文件系统、卫生管理、运输管理上优于中国GSP标准;GSP标准更加强调药品购进和验收环节的控制,将渠道管理和产品合法性审核作为药品经营企业质量管理的重点,是符合我国当前医药市场实际状况的。

Objective Chinese current GSP standards and GDP standards recommended by the WHO were compared and analyzed to find out we can learn from aspects.Methods Chinese current GSP（Good Supply Practice） is compared with WHO recommended GDP（Good Distribution Practice） in terms of the structure,scope,management process,premises and equipment as well as post-sale service.Results and Conclusion Similar in guideline preparation idea and management focus,GDP is more experienced in the documentation,hygiene control and transportation management,while GSP takes more efforts in receipt inspection and acceptance.Giving more emphasis on the supply chain management and product legislation review in the quality management of pharmaceutical product supply and distribution,GSP is in accordance with current pharmaceutical markets in China.