中国药业2016，Vol.25Issue(12)：13-14,15,3.
辽宁省药品批发企业GSP认证检查缺陷项目分析
Analysis of Defective Items Detected by GSP Certification in Drug Wholesale Enterprises
杨牧 1由东 1李乐1
作者信息
- 1. 辽宁省药品认证中心，辽宁 沈阳 110003
- 折叠
摘要
Abstract
Objective To analyze the on-site inspection results of under the GSP Certification for wholesale drug enterprises,and to pointed out the common problems and provide technical references for the further development of targeted regulatory measures. Methods The defective items which were found in the on-site inspection of 215 factory-times were collected in order to analyze the main problems of GSP quality system in the wholesale drug enterprises. Results The total defective items were found in 1 596 items,of which 28 were the main defects and 1 568 were the general defects. There were high proportion of defects in facility and equipment, personnel and training,storage and maintenance,quality management system documents. Conclusion The defective items under the GSP Certification are analyzed,so as to provide reference for consolidation stage effect and guarantee the quality of the drugs in supply as well as the healthy development of the enterprise.关键词
药品经营企业/药品经营质量管理规范/缺陷项目/改进措施Key words
drug wholesale enterprises/GSP/defective items/improvement measures分类
医药卫生引用本文复制引用
杨牧,由东,李乐..辽宁省药品批发企业GSP认证检查缺陷项目分析[J].中国药业,2016,25(12):13-14,15,3.
