安徽省药品批发企业申报新修订GSP认证缺陷分析

Defective Analysis of the Newly Revised GSP Certification for Drug Wholesalers in Anhui Province

目的:汇总分析安徽省批发企业实施新修订GSP中存在的普遍问题,探讨提高企业经营质量管理水平的措施,确保用药安全。方法:通过对95家药品批发企业实施新修订GSP认证中出现的缺陷项目的统计,找出最易出现的缺陷项目,逐一分析并提出解决对策。结果:高频次一般缺陷项目9项,合计达265频次,高频次主要缺陷9项,合计达44频次。结论:为提高临床用药安全,保证药品质量,需切实提高药品批发企业经营质量管理水平,加强对新修订GSP条款的理解,增强全体从业人员质量意识。

To analyze the general problems existing in the newly revised GSP certification for drug wholesales in Anhui province, find measures which can improve by discussion, and ensure drug safety . Methods： Through stating defects appeared in the newly revised GSP certification for 95 drug wholesales, we can find out more common defects, then we put forward some solutions after analyzing them one by one. Results： 9 average frequency of defective items, totaling 265 times, 9 main frequency of defects. Conclusion： The enterprise＇s quality control and management level is needed to improve to enhance the safety in clinic and ensure the quality of medicines. We should enforce our understanding of in the newly revised GSP terms, and raise all members＇ Analgsis and countermeasures qualitv consciousness.