摘要
作为药品生产实施GMP的源头,医药工程设计必须率先符合GMP。介绍工程设计符合GMP的法规依据,我国医药行业工程建设第一个国家标准《医药工业洁净厂房设计规范》的基本特点,以及与该规范有关的若干问题。
As the source of GMP implementation in pharmaceutical manufacture, the pharmaceutical plant design must comply with GMP first. The regulatory and lawful basis of pharmaceutical plant design in compliance with GMP, the features of the first state standard for pharmaceutical project in China ＂Design Code of Cleaning Workshop Used in Pharmaceutical Industry＂ and the related considerations were discussed.
出处
《洁净与空调技术》
2009年第4期63-68,共6页
Contamination Control & Air-Conditioning Technology
关键词
GMP
医药洁净技术
洁净室及相关受控环境
设计规范
GMP
Pharmaceutical cleanroom technology
Cleanroom and associated controlled environments
Design code
