制药用水系统现场检查的问题分析  

Analysis of pharmaceutical water system defects in drug inspection

作　　者：游小杰 颜若曦 YOU Xiaojie;YAN Ruoxi(Chongqing Center for Drug Evaluation and Inspection,Chongqing 401120,China;Center for Food and Drug Inspection of NMPA,Beijing 100076,China)

机构地区：[1]重庆市药品技术审评查验中心,重庆401120 [2]国家药品监督管理局食品药品审核查验中心,北京100076

出　　处：《现代药物与临床》2025年第1期211-214,共4页Drugs & Clinic

摘　　要：制药用水系统广泛应用于制药工业,通常分为制备系统和循环系统。在药品生产现场检查中发现制药用水系统的相关缺陷。对制药用水系统日常监测、确认与验证、运行维护、设计常见问题进行分析和总结,为制药企业提升制药用水系统管理水平提供参考,同时为药品检查工作提供借鉴。Pharmaceutical water systems are widely used in the pharmaceutical industry,and usually divided into preparation systems and circulation systems.Defects were found in the pharmaceutical water system in inspections of drug production sites.This article analyzes and summarizes common problems in the daily monitoring,confirmation and verification,operation and maintenance,and design of pharmaceutical water systems,providing reference for pharmaceutical companies to improve their management level of pharmaceutical water systems,and also providing reference for drug inspection work.

关 键 词：制药用水系统 日常监测 确认与验证 运行维护 设计 

分 类 号：R926[医药卫生—药学]