摘要
通过对国内外有关GMP对无菌分装粉针车间生产环境的要求进行了比较和分析,有助于在设计工作中更好地理解并实施我国GMP对无菌分装粉针车间的要求。
The comparison and the analysis of the GMP requirements for sterile packed powder injection workshop environment overseas and in China were carried out, which can help engineers understand and execute GMP requirements for sterile separation packed workshop better.
出处
《医药工程设计》
2006年第3期33-36,共4页
Pharmaceutical Engineering Design
关键词
无菌分装粉针药品
GMP
无菌作业区
验证
认证
Sterile separation packed powder injection medicine GMP Sterile work zone Verification Approval