新版GMP实施给洁净室带来的影响

摘要

通过对比新版GMP与1998版GMP在洁净厂房方面的规定,结合我国药品生产企业的实际情况进行研究。结论：新版GMP的实施将对我国药品生产企业产生较大影响,药品生产企业尤其是无菌制剂生产企业必须进行必要的改造。%This paper compares the regulations of clean rooms in the new version of GMP and 1998 version of GMP,combined with the current conditions in drug manufacturers in our country.Conclusion：The implementation of new version of GMP will greatly influence drug manufacturers in our country,especially aseptic preparation manufacturers.