药品生产企业洁净区气流流型测试关注点及常见问题分析  

Analysis of Key Points and Common Issues in Airflow Pattern Testing in Clean Rooms of Pharmaceutical Manufacturing Enterprises

作　　者：张平 周明皓 李武超 颜若曦 ZHANG Ping;ZHOU Ming-hao;LI Wu-chao;YAN Ruo-xi(Center for Food and Drug Inspection of NMPA;Center for Drug Inspection of Guizhou Medical Products Administration)

机构地区：[1]国家药品监督管理局食品药品审核查验中心 [2]贵州省药品监督管理局检查中心

出　　处：《中国食品药品监管》2024年第12期88-93,共6页China Food & Drug Administration Magazine

摘　　要：洁净区静态和动态生产状态下,具有良好的气流流型对洁净环境的控制与维持、污染控制和无菌保证等具有重要意义。药品生产企业在药品生产质量管理规范实施过程中,需要关注的内容和常见问题主要集中在气流流型测试方案的科学合理性和完整性、测试执行和记录、测试记录及报告的审核与分析等方面。本文总结了药品生产企业药品生产现场的气流流型测试适用范围、常用方法及其重点考虑因素等一般考虑,对相关关注点和近几年国内外药品生产现场检查中相关典型缺陷进行分析,并提出改进建议,以期为药品生产企业提升生产区域气流流型测试有效性和污染控制提供借鉴,并为相关内容的检查提供参考。Maintaining proper airflow patterns in clean rooms under both static and dynamic production conditions is crucial for controlling and sustaining a clean environment,contamination control,and sterility assurance.During the implementation of Good Manufacturing Practice(GMP)for pharmaceuticals,key concerns and common issues often center on the scientific validity,rationality,and completeness of airflow pattern testing protocols,as well as the execution,recording,and analysis of test results.This article summarize the scope of application,commonly used methods,and key considerations for airflow pattern testing in pharmaceutical manufacturing sites.It analyzes key points and typical deficiencies found in domestic and international inspections of pharmaceutical manufacturing sites in recent years,and proposes related improvement suggestions to enhance the effectiveness of airflow pattern testing and contamination control in production areas,while offering valuable references for related inspections.

关 键 词：气流流型 可视化测试 生产现场 关注点和缺陷分析 污染控制 

分 类 号：R95[医药卫生—药学]