摘要
智能制造与合规提升是医药企业发展关键途径,以浙江海正药业有限公司A1产品项目自动化新车间(含发酵/提取)为例,从生产自控"项目与验证"全生命周期管理的角度分析,探讨目前制药企业在工业4.0时代提升生产自控智能水平,并能符合中国新版GMP和美国FDA法规要求,完成GAMP5计算机化系统V模型验证的可行思路与实践方法。
Intelligent manufacturing and compliance improvement are the critical paths for pharmaceutical company devel- opment, for example, automatic workshop （containing fermentation/extraction） of A1 product of Zhejiang Hisun Pharmaceutical Co.,Ltd, from the view of production automation, ＂project and validation＂ , and full lifecycle management, we want to discuss how pharmaceutical company upgrades the automation level of production control while meeting the guideline requirement of Chinese current GMP and US FDA, and the feasible thinking and practical approach of GAMP5 computerized system V model validation.
出处
《仪器仪表用户》
2017年第7期5-10,共6页
Instrumentation
