山东省新修订药品GSP认证检查缺陷项目分析

Analysis of Defective Items Detected by New Revised Medicine GSP Certification and Inspection in Shandong Province

目的:分析企业在实施新修订的《药品经营质量管理规范》(GSP)过程中存在的主要共性问题,为今后制定有针对性的监管措施和全面推进药品GSP的实施提供技术参考。方法:对435家次药品批发企业GSP认证现场检查中发现的缺陷项目进行统计,分析药品批发企业GSP质量体系中存在的主要问题及其成因,并提出相应的对策。结果与结论:企业应进一步建立完善的质量管理体系;注重质量风险管理;提高培训的针对性和实效性。

Objective： To find out the main problems existing in the implementation of new revised medicine GSP in enterprises by collecting and analyzing the inspected defects so as to provide technical references for the further development of targeted regulatory measures and promote the comprehensive implementation of GSP. Methods： The defective items which were found in the on-site inspection of 435 factory-times were collected in order to analyze the main problems and causes of GSP quality system in the wholesale medicine enterprises, and to put forward the corresponding countermeasures. Results and Conclusion： The enterprises should further establish a perfect quality management system, attach importance to the management of quality risk, and improve pertinency and effectiveness of training.