摘要
目的:通过对河南省药品生产企业质量控制实验室的管理情况调查结果的分析,探讨质量控制实验室存在的不足及改善的方法。方法:采用随机样本法,从2013年认证检查、跟踪检查及专项检查药品生产企业名单中,随机抽取18家进行质量控制实验室情况调查。采用对比法,将调查结果与2010年版《药品生产质量管理规范》进行比较分析。结果:18家企业中,质量管理负责人本科及以上学历仅占44.4%,质量检验人员中无本科及以上学历,具有专科学历人员占27.8%,经过专业培训的人员占100%;仪器设备整体管理较好,但存放合格率仅达77.8%。结论:新版GMP推行以来,药品生产企业整改成效明显。质量控制实验室管理整体效果良好,但部分企业仍存在各种不足。规范化管理体系的建设仍需加强。
Objective： To explore methods to improve management of the quality control laboratory through investigation of pharmaceutical quality control laboratories in Henan Province. Methods： Using the random sample method, 18 quality control laboratories were selected for investigation from the pharmaceutical manufacturers undergoing authentication inspection, track inspection and special inspection in 2013. The investigation results were compared with the 2010 edition of drug production quality management standards. Results： In the 18 pharmaceutical manufacturers, only 44.4% of the quality management directors had bachelor degree or above, none of the quality inspection personnel had bachelor degree or above, 27.8% of the staff had college degree, and 100% of the staff had specific training. The overall equipment management was well, and the qualified rate of equipment storage was 77.8%. Conclusion： With the implementation of the new edition of GMP, the pharmaceutical manufacturers have effective rectification. The overall effect of management of the quality control laboratories is good, but problems still exist in some manufacturers. The construction ot standardized management system still needs to be strengthened.
出处
《中国药事》
CAS
2015年第2期136-140,共5页
Chinese Pharmaceutical Affairs
基金
河南省教育厅人文社科项目(编号2013-JD-10)
关键词
药品生产企业
质量控制实验室
质量管理体系
GMP
人员资质
仪器设备管理
pharmaceutical manufacturer
quality control laboratory
quality management system
GMP
personnel quality
instrument and equipment management
作者简介
张丽青，教授，人文学院院长，主要从事卫生质量管理研究；E-mail：hnzyzlq@126.com
