湖南省2008～2009年GSP认证现场检查缺陷分析和对策  

Deficiency inspection and countermeasures of good supply practice certification in Hunan during 2008-2009

作　　者：姚金成[1] 饶健[1] 曾令贵[1] 王铸辉[1] 管志美[1] 陆才洋[1] 王辉[2] 袁农[1] 

机构地区：[1]湖南省药品审评认证与不良反应监测中心,长沙410013 [2]上海理工大学,上海200093

出　　处：《中南药学》2010年第12期940-943,共4页Central South Pharmacy

摘　　要：目的掌握企业实施GSP的薄弱环节,为完善湖南省GSP认证工作以及提升湖南省药品经营企业的质量管理水平提供可行性建议。方法采用描述性统计的方法,统计分析湖南省2008～2009年GSP认证各市州药品经营企业分布情况和出现的高频缺陷情况,针对性提出相应的可行性建议。结果 2009年比2008年GSP认证企业数和通过率均有所提高,但企业仍存在记录不规范、GSP意识不强等问题。结论为保证GSP认证工作的长足健康发展和提升湖南省药品经营企业的质量管理水平,应从完善电子数据库,健全管理制度,强化GSP意识,建立检查员的聘用、考评与激励机制,提升企业规模和实力,完善GSP认证后的长效监督机制等多方面着手。Objective To determine the weak points in the implementation of good supply practice （GSP）, to enhance the quality management to provide feasible suggestions for GSP certification. Methods Statistical analysis was used in the GSP certification in all regions to detect deficiencies of high-frequency. Specific proposals were put forward in Hunan province during 2008--2009 by descriptive statistical methods. Results The number of enterprises and the adoption of GSP certification rate increased in 2009, but records were not standardized, and GSP awareness was not strong enough. Conclusion To ensure the rapid and healthy development of GSP certification in enterprises and to enhance the management of drug quality in Hunan, we should improve the database, establish a sound management system, strengthen GSP awareness, build inspector appointment, evaluation and incentive mechanism, and improve the longterm supervision mechanism.

关 键 词：GSP认证 检查报告 缺陷项目 

分 类 号：R954[医药卫生—药学]