药学研究2025，Vol.44Issue(12)：1194-1199,6.DOI:10.13506/j.cnki.jpr.2025.12.008
生物制品药学研制核查要点和常见问题分析
The key points and common problem analysis for pharmaceutical research and development of biological products
张平 1宋凯2
作者信息
- 1. 国家药品监督管理局食品药品审核查验中心,北京 100076
- 2. 山东省食品药品审评查验中心,山东济南 250014
- 折叠
摘要
Abstract
In the production and quality control of biological products,there are considerable variabilities and specific characteristics.Under the new regulatory framework for drug registration,on-site inspections serve as a crucial supervisory tool to facilitate the authenticity and traceability of data in biological products research and development(R&D),and to promote its industry standardization and high-quality development.Based on the characteristics of biological products and practical inspection experiences in recent years,this article summarized and analyzed the key focus points and common issues identified during the on-site inspections of the CMC(chemistry,manufacturing,and controls)research and development of biological products.The aim is to provide insights for biological products R&D and registration,as well as to offer reference for conducting related inspections.关键词
生物制品/药学研制/核查要点/处方设计Key words
Biological products/Pharmaceutical research and development/Key points of inspection/Prescription design分类
医药卫生引用本文复制引用
张平,宋凯..生物制品药学研制核查要点和常见问题分析[J].药学研究,2025,44(12):1194-1199,6.
