中国药物评价2025，Vol.42Issue(2)：86-90,5.
生物制品分段生产质量管理要点探讨
The Analysis of Key Points in Quality Management for Segmented Production of Biological Products
韩雨 1颜若曦1
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
- 折叠
摘要
Abstract
In order to support the high-quality development of the biomedical industry,the NMPA has initiated a pilot program for seg-mented production of biological products.As this pilot program gradually unfolds,the traditional single-site production model of biological products has shifted to segmented production at different sites.This may introduce some new potential risks,such as the unification and cohesion of the quality management systems of the holder of the drug marketing authorization and the segmented production enterprises,the consistency of production processes and quality control under the segmented production model,and the performance and technical risks re-lated to the transfer and handover of intermediate products.This article analyzes and discusses the key points of quality management for segmented production of biological products by sorting out relevant regulatory guidelines on commissioned production and segmented pro-duction of biological products,combining the characteristics of biological products,and focusing on the differences and risk points under the segmented production model,starting from the six major systems of drug production quality management.It aims to provide ideas and references for Chinese biological product manufacturers to adapt to the new model of industrial development and further improve quality management,while also providing reference for drug inspection.关键词
生物制品/分段生产/六大系统/生产质量管理Key words
Biological products/Segmented production/Six major systems/Production quality control分类
药学引用本文复制引用
韩雨,颜若曦..生物制品分段生产质量管理要点探讨[J].中国药物评价,2025,42(2):86-90,5.
