关于《兽药生产质量管理规范(2020年修订)》洁净区域静态检测要求的理解  

Understanding of cleanroom-controlled environment static inspection requirements based on Good manufacturing practices for veterinary drugs(revised in 2020)

作　　者：陈紫光 曹国庆 党宇 曹冠朋 高鹏 谭鹏 赵倩玉 李洪庆 吴彩红 李国梁 Chen Ziguang;Cao Guoqing;Dang Yu;Cao Guanpeng;Gao Peng;Tan Peng;Zhao Qianyu;Li Hongqing;Wu Caihong;Li Guoliang(China Academy of Building Research,Beijing;Inner Mongolia Bigvet Biotech Co.,Ltd.,Hohhot;TECON Co.,Ltd.,Suzhou)

机构地区：[1]中国建筑科学研究院有限公司,北京市100013 [2]内蒙古必威安泰生物科技有限公司,呼和浩特 [3]天康制药股份有限公司,苏州

出　　处：《暖通空调》2023年第9期12-19,11,共9页Heating Ventilating & Air Conditioning

基　　金：中国建筑科学研究院有限公司青年科研基金资助项目“空气过滤器表面截留微生物存活时间与衰减趋势研究”(编号:20220109331030021);室内空气质量评价与控制北京市重点实验室开放基金课题“医院建筑生物安全防控关键技术研究”(编号:BZ0344KF20-04)。

摘　　要：对比分析了我国2版兽药生产质量管理规范(GMP)(2002版与2020版)关于洁净受控环境技术指标的修订变化。结合农业农村部389号公告与笔者现场检测经验,梳理总结了新版兽药GMP执行背景下的生产厂房洁净受控环境静态检测工作实施要点与评价依据,重点介绍了对洁净度(悬浮粒子浓度)、A级区域截面风速、气流流型、自净时间、送风高效过滤器检漏等新版兽药GMP新增或重点修订检测项目的理解要点。This paper reviews and compares the requirements of key parameters of cleanroom-controlled environment based on the two versions of Good manufacturing practices for veterinary drugs(2002 and 2020,respectively).Combined with the announcement No.389 of the Ministry of Agriculture and Rural Affairs and the author's on-site inspection experience,the key points and evaluation basis of cleanroom-controlled environment inspection in static state in the GMP 2020 for veterinary drugs are summarized,focusing on the new and key revised items of GMP 2020,such as the cleanliness(suspended particle concentration),sectional wind speed in the A-class area,air flow pattern,self-cleaning time,and integrity check of HEPA of supply air flow.

关 键 词：兽药 生产质量管理规范(GMP) 洁净受控环境 检验与检测 评价 

分 类 号：S859[农业科学—临床兽医学]