广东省新版GSP认证现场检查情况分析  

Analysis of on-Site Inspection Situation in New Version of GSP Certification in Guangdong

作　　者：曾祥卫[1] 颜红[1] 苏永梅[1] 梁杰康[1] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广东广州510080

出　　处：《今日药学》2015年第10期741-744,共4页Pharmacy Today

摘　　要：目的分析药品批发及零售连锁企业新版GSP认证现场检查结果的情况,指出常见的问题,通过问题的分析提出建议,促进药品经营企业在日常经营中进一步规范实施新版GSP,以及提高GSP认证检查员现场检查能力。方法对2013-2015期间1 803份广东省药品批发及零售连锁企业新版GSP认证现场检查结果,采用计量学方法进行分类统计分析。结果设施与设备方面出现过缺陷项目的共有1 951次;人员与培训方面出现过缺陷项目的共有1 753次;采购方面出现过缺陷项目的共有1 180次;储存与养护方面出现过缺陷项目的共有892次;质量管理系统文件方面出现过缺陷项目的共有475次。结论批发及零售连锁企业在新版GSP实施后对药品的质量管理得到进一步提升,企业药品经营行为显著规范,尤其对药品购销渠道及在流通环节药品温湿度条件采取更严格的管控。本文通过对缺陷项目的分类统计,分析企业在新版GSP认证的具体存在问题和原因,为进一步巩固新版GSP认证的阶段性效果、保障药品在流通环节的质量、促进企业的健康发展提供参考。OBJECTIVE To analyze the on-site inspection results of drug wholesale and retail chain enterprises under the new version of GSP certification,and to pointed out the common problems. To promote the wholesale and retail chain drug enterprises in the daily operation and the inspector ability as to meet the requirements of the implementation of the new version of GSP,through the analysis of the common problems form certification inspection in Guangdong. METHODS A total of 1 803 results of the new version of GSP inspection from 2013 to 2015 in Guangdong province were analyzed by metrology method. RESULTS There were 1951 times project defects in the facility and equipment,and 1753 times project defects in the personnel and training,1 180 times project defects in the procurement,and 892 times project defects in the storage and maintenance. CONCLUSION After the new version of GSP implementation,the wholesale and retail chain of drug quality management has been further enhanced,especially for drug distribution channels and temperature and humidity preservation conditions were taken more strict control. In this paper,the problems and causes of the defects of the GSP certification were analyzed,so as to provide reference for consolidation stage effect,the quality guarantee of the drugs in supply and the healthy development of the enterprise.

关 键 词：药品批发及售连锁企业 新版GSP 现场检查 缺陷项目 

分 类 号：R95[医药卫生—药学]