摘要
在对国内外关于药品工艺验证有关法规指南分析的基础上,明确了工艺验证的基本原则与要求。通过对近几年国内外药品检查中发现的药品生产企业在工艺验证方面存在缺陷的分析,对工艺验证中的常见问题进行总结、分类与提炼。为我国制药行业进一步做好工艺验证提供参考,同时也为工艺验证的检查提供借鉴。
Based on the study of domestic and foreign rules and guidelines about drug process validation,the basic principles and requirements of process validation were defined.Though the analysis of observations of process validation in domestic and overseas drug inspections in recent years,it summarizes and refines the common problems in process validation.It provides suggestions and reference for the pharmaceutical industry to further improve the process validation,and provides reference on inspection on process validation efficiently.
作者
翟铁伟
颜若曦
王立杰
ZHAI Tie-wei;YAN Ruo-xi;WANG Li-jie(Center for Food and Drug Inspection of NMPA,Beijing 100044,China)
出处
《中国药物评价》
2021年第5期380-382,共3页
Chinese Journal of Drug Evaluation
关键词
验证与确认
生产工艺
工艺确认
工艺验证
Validation and Qualification
Production Process
Process Qualification
Process Validation
