摘要
Abstract
OBJECTIVE: To provide reference for pharmaceutical manufacturers to study the new requirements of new version of GMP and rebuild the clean room. METHODS: By studying the relevant requirement of clean room in new and previous version of GMP, the factors which affected the development of clean room were analyzed to put forward suggestions. RESULTS & CONCLUSIONS: New version of GMP is different from previous version in terms of clean area scale, determination of suspended particle, wind speed of air outlet, pressure differential of adjoining room at same clean scale, etc. The key points to rebuild clean room are pressure differential, air output and input, air distribution way, wind speed of air outlet, ventilation rate, etc. So that, rebuilding of clean room can be achieved by 2 kinds of conditions, I.e. Changing the number of air outlet or not.关键词
药品生产质量管理规范/新版/旧版/洁净室/改造Key words
GMP/ New version/ Previous version/ Clean room/ Rebuilding分类
管理科学
