社会药店药品经营质量管理规范认证检查中存在的问题分析及对策

目的 分析社会药店药品经营质量管理规范认证检查中发现的缺陷问题,探讨进一步改善对社会药店监管的措施及对策。 方法 对65家社会药店药品经营质量管理规范认证现场检查报告中出现的缺陷项目进行统计,分析存在的主要问题。 结果 共发现缺陷项396项次,其中主要缺陷项目168项次,一般缺陷项目228项次,平均每家6.1条缺陷项。缺陷项目频率较高的主要集中在人员管理、文件、采购与验收方面。 结论 贯彻实施药品经营质量管理规范,深化药品零售监管,应强化宣传教育和培训,加强监管队伍建设,建立信用监管机制,提高舆论监督作用。

Analysis and countermeasures on the problems of GSP certification examination

Objective To analyze the problems found in GSP certification examination of drug store,discuss the measures and countermeasures to improve the supervision. Methods The defects in the field inspection report of GSP certification in 65 drug stores were statistically analyzed and the main problems were analyzed. Results Among the 396 defect projects,there are 168 major defect projects and 228 general defect projects,6.1 defect projects on the average.The high frequency of defects is mainly focused on personnel management,documentation,procurement and acceptance. Conclusion In order to implement the GSP and the supervision of drug retail,we should strengthen publicity,education and training,strengthen the supervision team building,establish a credit supervision mechanism,and improve the role of public opinion supervision.