摘要
就新颁布的《医药工业洁净厂房设计规范》,对照即将颁布的新版GMP,对药品生产企业污染控制进行研究。新的《洁规》和新GMP都对药品生产企业污染控制标准提出了更高的要求,同样,如果药品生产企业严格执行新的《洁规》和新GMP,污染的控制管理水平也能得到很大提高。
This article is discussing contamination control in clean rooms of pharmaceutical enterprise based on newly issued"Code for Design of Pharmaceutical Industrial Clean Rooms"and the new version of GMP which will be issued soon.More strict requirements for contamination control standards of pharmaceutical enterprises have been prescribed in the new code and new version of GMP.Moreover,if the new code and the new version of GMP have been implemented by pharmaceutical enterprises strictly,the management level of contamination control will be improved significantly.