摘要
近年来,在国内外生物制品生产现场检查中发现生产设备方面的问题较为突出。对生物制品生产设备的检查是基于药品生产质量管理规范(GMP)标准规定开展的,因此对无菌生物制品原液生产设备、制剂生产设备和一次性使用系统的检查要点进行总结和分析,并列举了国内外生物制品检查典型问题,探讨在各类检查和自查中如何提高对生物制品生产设备的检查实效,同时也为生物制品行业进一步加强生产设备的管理提供参考。
In recent years,prominent issues have been found in the production equipment during on-site inspections of biological products at home and abroad.The inspection of biological product production equipment is based on the provisions of Good Manufacturing Practice(GMP)standards for drug production.This article summarizes and analyzes the inspection points of sterile biological bulk and finished product production equipment,formulation production equipment,and single-use system,and lists typical problems in biological product inspection at home and abroad.It explores ways to improve the inspection effectiveness of biological product production equipment in various inspections and self-inspections,and also provides reference for further strengthening the management of production equipment in the biological product manufacturers.
作者
颜若曦
YAN Ruoxi(Center for Food and Drug Inspection of NMPA,Beijing 100076,China)
出处
《现代药物与临床》
CAS
2024年第2期497-502,共6页
Drugs & Clinic
关键词
生物制品
生产设备
一次性使用系统
原液
制剂
检查要点
biological product
production equipment
single-use system
bulk
finished product
key inspection points
