生物制品屬于較高染菌風險的品種，生產(chǎn)多涉及無菌生產(chǎn)過程，因此需要制定環(huán)境監(jiān)測要求。生物制品生產(chǎn)環(huán)境監(jiān)測現(xiàn)場檢查要點包括環(huán)境監(jiān)測風險評估、環(huán)境監(jiān)測程序文件的制定和實施過程控制、A/B級區(qū)域的環(huán)境監(jiān)測、環(huán)境監(jiān)測結果的定期回顧。環(huán)境監(jiān)測檢查發(fā)現(xiàn)的典型缺陷主要集中在監(jiān)測點位與頻次風險評估、回顧與趨勢分析、監(jiān)測報警與偏差處理、日常監(jiān)測與操作規(guī)范性、數(shù)據(jù)可靠性方面。對生物制品生產(chǎn)環(huán)境監(jiān)測現(xiàn)場檢查要點進行分析，并對國內(nèi)各類檢查中發(fā)現(xiàn)的常見問題進行分析總結，旨在為生物制品企業(yè)、生物制品檢查員進一步做好藥品生產(chǎn)潔凈環(huán)境監(jiān)測、檢查提供參考和借鑒。

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.

R971