浙江省人用疫苗生产企业采暖通风与空调调节系统检查缺陷分析  

Defects in Heating,Ventilation,and Air Conditioning System Inspection of Human Vaccine Manufacturers in Zhejiang Province

作　　者：王宇 沈泓 刘琛 陈晓玉 邓祖跃 周明昊 陈雪园 WANG Yu;SHEN Hong;LIU Chen;CHEN Xiaoyu;DENG Zuyue;ZHOU Minghao;CHEN Xueyuan(Zhejiang Institute for Food and Drug Control,Hangzhou,Zhejiang,China 310052;Zhejiang Drug Inspection Center,Hangzhou,Zhejiang,China 310063;Zhejiang Pharmaceutical University,Ningbo,Zhejiang,China 315500)

机构地区：[1]浙江省食品药品检验研究院,浙江杭州310052 [2]浙江省药品检查中心,浙江杭州310063 [3]浙江药科职业大学,浙江宁波315500

出　　处：《中国药业》2024年第7期28-31,共4页China Pharmaceuticals

基　　金：浙江省药品监管系统科技计划项目[2021029]。

摘　　要：目的为我国疫苗的监管及其行业发展提供参考。方法对浙江省人用疫苗生产企业2017年至2021年各类官方检查中有关采暖通风与空调调节(HVAC)系统的缺陷进行梳理和分析,从缺陷分布、缺陷产生原因等方面剖析疫苗生产企业存在的问题。结果与结论疫苗生产企业需完善质量管理体系文件,加强人员培训;科学评估,加强环境微生物动态监测;科学设计厂房及设施、设备,做好日常维护;落实疫苗生产车间HVAC系统生物安全相关要求,提升全员生物安全意识。Objective To provide a reference for the regulation and industry development of vaccines in China.Methods The defects related to heating,ventilation,and air conditioning(HVAC)system in various official inspections of human vaccine manufacturers in Zhejiang Province from 2017 to 2021 were sorted out and analyzed,and the problems of vaccine manufacturers in the HVAC system were analyzed from the aspects of defect distribution and causes of defects.Results and Conclusion Vaccine manufacturers should improve their quality management system documents and strengthen personnel training,conduct scientific assessments and strengthen dynamic monitoring of environmental microorganisms,scientifically design plants,facilities and equipment,and carry out daily maintenance,implement biosafety-related requirements for the HVAC system in vaccine production workshops,and enhance the biosafety awareness of all staff.

关 键 词：采暖通风与空调调节系统 人用疫苗检查 检查缺陷 生物安全 浙江省 

分 类 号：R95[医药卫生—药学]