摘要
通过调查研究的方法,找到我国制药企业在首次工艺验证中普遍存在的问题,借助对国内外法规及相关文献研究,并结合我国制药企业的现状,提出对问题的解决策略,该研究对我国制药企业有效开展首次工艺验证有一定的指导意义。
Through the research method to find the problems existing in the initial process validation of domestic pharmaceutical enterprises. Solutions were put forward to the existing problems through studying the regulations and combined with the current situation of Chinese pharmaceutical enterprises. This study give effective instruction to the pharmaceutical enterprises to conduct the initial process validation.
作者
贾欣秒
杨悦
赵俭
JIA Xinmiao;YANG Yue;ZHAO Jian(College of Business Administration,ShenYang Pharmaceutical University,Liaoning Shenyang 110016,China;North China Pharmaceutical Co.,Ltd.,Hebei Shijiazhuang 050015,China)
出处
《中国药物评价》
2018年第2期148-153,共6页
Chinese Journal of Drug Evaluation
关键词
工艺验证
首次工艺验证
工艺确认
质量源于设计
质量风险管理
统计分析技术
Process validation
Initial process validation
Process qualification
Quality by design
Quality risk management
Statistic analysis technology
