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

目的分析药品批发企业《药品经营质量管理规范》(简称GSP)认证现场检查结果,指出常见问题,为今后制订有针对性的监管措施提供技术参考。方法统计辽宁省215家药品批发企业GSP认证现场检查中发现的缺陷项目,并分析存在的主要问题。结果共发现缺陷项目1 596项,其中主要缺陷28项,一般缺陷1 568项。缺陷比例较高的项目为设施与设备、人员与培训、储存与养护、质量管理体系文件。结论通过分析药品批发企业在实施GSP过程中存在的问题,可为进一步巩固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 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.