我国新修订GMP认证的现状、困境及对策研究  

Research on current situation,difficulties and specific suggestions of certification of the new version of GMP

作　　者：颜建周[1] 邵蓉[1] 

机构地区：[1]中国药科大学医药产业发展研究中心,江苏南京211198

出　　处：《药学研究》2014年第6期311-314,318,共5页Journal of Pharmaceutical Research

基　　金：国家社会科学基金(No.11BFX098);中国药科大学医药产业发展研究中心社会科学研究基金(No.CPUSJ1308)

摘　　要：本文在分析我国新修订GMP认证工作现状的基础上,从认证理念、认证成本、融资渠道和认证配套机制等方面总结了当前新修订GMP认证中遇到的困境。以此为依据,结合山东等典型省份的实践经验提出转变企业消极对待新修订GMP认证的观念,加快认证进度;开拓融资渠道,缓解企业认证资金压力;设置专职的GMP检查员队伍,提高认证效率;健全市场退出机制,消除拟退出企业后顾之忧等推进我国新修订GMP认证工作的政策建议。This paper analyzed the current situation of GMP certification,concluding the difficulties and problems in certification process in terms of certification concepts,costs,financial sources and related mechanisms,providing specific suggestions on the basis of representative provinces such as Shandong. Suggested that we should change the enterprises′ negative attitude toward GMP certifica-tion,accelerate certification process;broaden financial sources to relieve the fund pressure of enterprises;set up full-time GMP inspec-tors pool to improve the efficiency of certification;perfect market withdrawal mechanism to eliminate the worries of enterprises.

关 键 词：新修订GMP认证 专职GMP检查员 退出机制 

分 类 号：R951[医药卫生—药学]