摘要
比较中美两国GMP立法的差异,即中美两国GMP在法律和文化上的不同。中国制药企业要达到美国FDAcGMP符合性,应加强建立程序和证据。
In this article, the legal and cultural differences between Chinese GMP and US FDA cGMP were compared. To reach the requirements of US FDA cGMP, Chinese pharmaceutical enterprises should more strengthen the control on procedure and evidence.
出处
《医药工程设计》
2007年第6期43-46,共4页
Pharmaceutical Engineering Design
