生物制品属于较高染菌风险的品种，生产多涉及无菌生产过程，因此需要制定环境监测要求。生物制品生产环境监测现场检查要点包括环境监测风险评估、环境监测程序文件的制定和实施过程控制、A/B级区域的环境监测、环境监测结果的定期回顾。环境监测检查发现的典型缺陷主要集中在监测点位与频次风险评估、回顾与趋势分析、监测报警与偏差处理、日常监测与操作规范性、数据可靠性方面。对生物制品生产环境监测现场检查要点进行分析，并对国内各类检查中发现的常见问题进行分析总结，旨在为生物制品企业、生物制品检查员进一步做好药品生产洁净环境监测、检查提供参考和借鉴。

Biological products belong to varieties with high risk of bacterial contamination, and their production often involves aseptic production processes, therefore environmental monitoring requirements need to be formulated. The key points for on-site inspection of environmental monitoring in the biological products production include environmental monitoring risk assessment, development and implementation process control of environmental monitoring procedure documents, environmental monitoring of A/B-level areas, and regular review of environmental monitoring results. The typical defects found in environmental monitoring inspections mainly focus on monitoring point location and frequency risk assessment, review and trend analysis, monitoring alarm and deviation handling, daily monitoring and operational standardization, and data reliability. This article analyzes the key points of on-site inspection for monitoring the production environment of biological products, and summarizes the common problems found in various inspections in China, to provide reference and guidance for biological product enterprises and biological product inspectors to further monitor and inspect the clean environment of drug productions.

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