摘要
目的研究计算机化系统在GMP中的应用,并对实施中的具体问题提出可行方案。方法通过对计算机化系统内涵,以及其应用的必要性和具体手段研究介绍,提出在实际应用中遇到问题的解决方案。结果与结论计算机化系统在GMP中的应用符合制药行业发展的要求,但仍存在一些问题,需要提出方案解决。
Objective To research the application of computerized system in GMP and propose methods to the issues concerned with implementation. Methods By elaboration on the essence of computerized system, its importance of application and the specific application method, proposals to settle the problems occurred during practical application are put forward. Results and Conclusions The application of computerized system in GMP is in accordance with the development demand of pharmaceutical industry; yet, there are still some problems to be solved.
出处
《中国药事》
CAS
2009年第5期483-486,共4页
Chinese Pharmaceutical Affairs
关键词
GMP
计算机化系统
验证
电子记录
GMP
computerized system
validation
electronic record
