山东省药品GSP认证检查缺陷项目分析.pdfVIP

中国药事 2015 年 7 月 第 29 卷 第 7 期 721 山东省药品 GSP 认证检查缺陷项目分析 * 陈洪忠，冉大强，林晓明，胡敬峰 （山东省食品药品监督管理局审评认证中心，济南 250013） 摘要 目的：发现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：企业应进一步完善质量管理体系；注重质量风险管理； 提高培训的针对性和实效性。 关键词： 药品 GSP；缺陷项目；分析 中图分类号：R954.2 文献标识码：A 文章编号： 1002-7777(2015)07-0721-04 doi:10.16153/j.1002-7777.2015.07.010 Analysis of Defective Items Detected by Medicine GSP Certification and Inspection in Shandong Province * Chen Hongzhong, Ran Daqiang, Lin Xiaoming, Hu Jingfeng (Center for Drug Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250013, China) Abstract Objective: To find out the main problems existing in the implementation of revised GSP in the enterprises by collecting and analyzing the inspected defects, so as to provide technical references for the further development of targeted regulatory measures and to promote the comprehensive implementation of GSP. Methods: The defective items which were found in the on-site inspection of 435 factories were summarized in order to analyze the main problems and causes of GSP quality system in the wholesale medicine enterprises and put forward the corresponding countermeasures. Results and Conclusion: The enterprises should further establish a sophisticated quality management system, attach importance to the management of quality risk, and improve pertinency and effectiveness of training. Keywords: medicine GSP; defective items; analysis [1] 《药品经营质量管理规范（2012 年修订）》 1 检查的总体情况 （以下简称“新修订药品 GSP”）于 2013 年 6 月 1.1 检查企业数量 1 日实施，山东省食品药品监督管理局审评认证中