药品生产企业消毒管理常见问题分析
Analysis of common problems in disinfection management of pharmaceutical manufacturers
张平 1游小杰 2颜若曦1
作者信息
- 1. 国家药品监督管理局 食品药品审核查验中心,北京 100076
- 2. 重庆市药品技术审评查验中心,重庆 401120
- 折叠
摘要
目前药品生产企业在药品生产质量管理规范的实施过程中,生产场地消毒管理方面存在的问题比较突出.消毒相关缺陷出现频率较高的问题包括消毒策略制定、消毒验证、消毒程序文件、消毒执行、消毒剂管理.对药品生产企业药品生产现场的消毒相关缺陷进行分析,并提出改进建议,以期为药品生产企业提升消毒管理提供借鉴.
Abstract
At present,there are prominent problems in disinfection management of drug production sites in the implementation of GMP by pharmaceutical manufacturers.Disinfection related deficiencies occur frequently,including disinfection strategies formulation,disinfection validation,disinfection procedure documents,disinfection execution,and disinfectant management.This article analyzes the disinfection related deficiencies in drug production sites of pharmaceutical manufacturers and proposes improvement suggestions,in order to provide reference for pharmaceutical manufacturers to improve disinfection management.
关键词
药品生产企业/消毒管理/消毒策略制定/消毒验证/消毒程序文件/消毒执行/消毒剂管理Key words
pharmaceutical manufacturer/disinfection management/disinfection strategies formulation/disinfection validation/disinfection procedure document/disinfection execution/disinfectant management引用本文复制引用
出版年
2024
NETL
NSTL
万方数据