浅谈口服固体制剂在新版GMP下的工艺设计

Brief Discussion on Technological Design of Oral Solid Dosage Forms Based on New GMP

介绍了口服固体制剂生产的法规背景和技术背景,提出了口服固体制剂在新版GMP下的工艺设计方法,使其最大限度地降低药品生产过程中污染、交叉污染以及混淆、差错的风险。

The author introduced regulation and technology backgrounds of producing oral solid dosage forms, and put for-ward methods of technological design of oral solid dosage forms based on new GMP, which furthest reduced risks of pollu-tion in process of drugs, cross contamination, confusion and errors.