摘要
Abstract
The consistency evaluation of generic drugs,as an important measure to improve the quality of generic drugs,is significant for advancing the upgrading of pharmaceutical industries,promoting the supply side reform as well as improving public health benefits.At present,the consistency evaluation of generic drugs is the most important work of enterprises.Since the variety of drug products,tight time schedule and heavy tasks,it is necessary to strengthen the quality management in the process of consistency evaluation of generic drugs,so as to enhance the quality and efficiency of consistency evaluation research.As a result,guarantee the completion of consistency evaluation in both quality and quantity.Aiming at the features of consistency evaluation research work,this article,combined with the problems and status quo of research,applies the advanced quality management concepts-quality by design (QbD) and plan-do-chenk-action (PDCA) management model to the consistency evaluation research work.Also we present the balance control strategy for evaluating the research quality and progress.As results,establishing an evaluation research model for the enterprises with equal importance of quality and progress.关键词
一致性评价/质量管理Key words
consistency evaluation/quality management分类
医药卫生
