黑龙江省药品生产企业GMP认证缺陷项目分析

Analysis of GMP Certification Defective Iten of Pharmaceutical Manufacturers in Heilongjiang Province

目的：了解黑龙江省药品生产企业新版GMP认证现场检查缺陷项目情况,分析企业实施新版GMP存在的共性问题,提出加快推进本省药品生产企业实施新版GMP的对策和建议。方法：对黑龙江省2012年~2014年认证的94家药品生产企业缺陷项进行汇总,对高频缺陷进行分析,对主要问题进行总结、分类、归纳。结论：应加大培训力度,建立专职检查员队伍,软硬件并重,确保新版GMP得到正确贯彻实施。

Objective： Putting forward countermeasures and suggestions on accelerating pharmaceutical manufacturers to imple- ment current GMP through analyzing observations of the current GMP certification on-site inspection to pharmaceutical production en- terprises in Heilongjiang Province and analyzing common problems of enterprises implementing the current GMP. Methods： Gathering observations of 94 pharmaceutical manufacturers which approved by our centre from 2012 to 2014, analyzing high-frequency observations, summarizing and classifying main issues. Conclusion： To ensure correct and thorough implementation of the new version of GMP, we should increase training efforts, set up full-time inspector team and pay equal attention to both hardware and software.