摘要
《药品经营质量管理规范》(2012年修订版)已经于2013年6月1日开始实施。新版GSP对中国药品生产企业和药品经营企业都提出了很高的要求。药品经营企业的计算机系统验证问题,尽管在某些中国药品经营企业已有涉及,但是很多企业理解不全面或者不深刻。笔者汇集并分析了关于计算机系统验证相关法规和指南,进行系统研究,撰写此文希望为中国药品企业提供借鉴和帮助。
＂Good supply practice for drug＂ （2012 version） has been issued in February 2013, and will be implemented on June 1, 2013. In the new version of GSP, strict requirements are stipulated for Chinese pharmaceutical manufacturers and pharmaceutical enterprises： for example, the introduction of the concept of risk management, the introduction of modem quality system, requirement of implementing computer systems validation, requirement of implementing cold chain validation. This new version of GSP bound to be enormous and far- reaching impact on Chinese pharmaceutical manufacturers and pharmaceutical enterprises. Although in some Chinese pharmaceutical enterprises computer system validation issues have been involved, however, these issues have not been fully or deeply understood in many companies. The authors pooled and analyzed computer systems validation regulations and guidelines and fulfilled this writing after carrying out systematic research. It was hoped that with this article some references and helps can be provided for Chinese pharmaceutical enterprises.
出处
《化工与医药工程》
2014年第1期25-28,共4页
Chemical and Pharmaceutical Engineering
关键词
药品经营质量管理规范
风险管理
计算机系统
验证
用户需求标准
确认
Good supply practice for drugs
risk management
computer system
validation
user requirement specification
qualification
