摘要
EU GMP附录11计算机系统是关于制药行业计算机系统管理和验证的权威指南。在修订以后,国际制药工程协会(ISPE)组织相关专家对这个附录进行了详细研究并逐条进行了注释和阐释。随着新版GMP的实施,计算机系统的管理和验证越来越被制药行业所关注和研究。这份技术注释文件不仅对研究EU GMP很有帮助,也必将对制药行业产生深远影响。笔者对这个指南文件进行翻译和系统研究,撰写此文,希望可以为中国制药行业提供借鉴和帮助。
Annex 11 ＂Computer system＂ in EU GMP the authorized guidance for the management and validation of computer system used in pharmaceutical industry.After being revised,this annex was studied by the experts appointed by ISPE and then explained.With the execution of new GMP,the management of computer system is being paid more and more attention.This technical explanation is not helpful to the studying of EU GMP but also has profound influence in pharmaceutical industry.The objective of this article is to provide reference and help for peoples working in Chinese pharmaceutical industry.
出处
《医药工程设计》
2013年第1期36-40,共5页
Pharmaceutical Engineering Design
