摘要
论述了无菌检查的局限性,并就此建议新版药典引入定量的相对无菌标准;实施GMP并完全信赖其对药品的无菌保证,而对最终灭菌药品施行“参数放行法”。
The limits of sterility test approach were analyzed and the corresponding solution was offered that quantitative sterility assurance level should be specified in the new edition of Chinese Pharmacopoeia and parametric release of terminally sterilized products should be executed based on implementation of GMP.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2000年第3期140-142,共3页
Chinese Journal of Pharmaceuticals
关键词
GMP
最终灭菌
无菌检查
无菌保证值
GMP
terminal sterilization
sterility test
sterility assurance level
