药品生产偏差管理探讨

iscussion of Deviation Management in Pharmaceutical Production

通过在制药企业里进行药品生产偏差管理的实践,从遇到的实际问题入手提出偏差管理存在的问题,以及在管理理念上需要提高偏差管理认识,建立符合企业实际情况和科学的偏差管理程序,加强偏差管理现场培训及跟进处理,让偏差能够得到及时报告、调查和处理,通过偏差管理不断加深对工艺过程的理解和管控,防止污染、交叉污染、混淆和差错的发生。

With the practice of deviation management for production in pharmaceutical enterprises,some problems which were actually existed were presented.It is indicated in this article necessary cognition in deviation management should be enhanced so that the practical and scientific deviation management procedure can be established.Any deviation should be reported,investigated and treated in time.Through deviation management,the understanding and controlling of processes may be continuously deepened,and in this way any contamination,cross contamination,confusion and error can be avoided.