WHO 2005年版GDP对我国GSP修订的启示

Enlightenment of 2005 Edition of GDP Recommended by WHO on Revision of GSP in China

目的:为我国《药品经营质量管理规范》(GSP)的修订提供参考。方法:分析比较世界卫生组织(WHO)推荐的《药品配送管理规范》(GDP)与我国新版GSP(征求意见稿)的差异,进而提出修订建议。结果与结论:GSP(征求意见稿)与GDP相比还存在一些差距,GSP(征求意见稿)应加强药品使用环节管理,扩大GSP的适用范围;完善质量管理体系,强化对假劣药品的防范;增加药品进口的管理规定;进一步完善仓储与运输管理规定;加强药品的运输、投诉、召回和退货管理等。应建立覆盖整个药品供应链的完善的质量管理体系,以保证药品质量的稳定性和可追溯性。

OBJECTIVE： To provide reference for revising Good Supply Practice （GSP） in China. METHODS： The differences of Good Distribution Practice （GDP） recommended by WHO from new GSP （consultative paper） in China were compared in term of circulation field to put forward revision suggestions. RESULTS ＆ CONCLUSIONS： There is a little gap between GSP （consultative paper） and GDP. It is suggested to strengthen the management of drug use in GSP （consultative paper）, and expand the usage range of GSP; improve quality management system, and strengthen the prevention of counterfeit and low quality drugs; increase the regulation of drug import management; further improve the rules of storage and transportation; enhance management of transportation, complaint, recall and goods returned, etc. A complete quality management system covering the whole drug supply chain should be built to ensure the stability of drug quality and drug traceability.