质量源于设计在疫苗灌装车间空调系统合规性改造中的应用  

Application of Quality by Design in compliance renovation of air conditioning system in vaccine filling workshop

作　　者：邱野 杨晓林 褚东琳 赵俊鑫 付博 孙国业 柏钦 陈宁 刘珂 常靖 姜崴 QIU Ye;YANG Xiaolin;CHU Donglin;ZHAO Junxin;FU Bo;SUN Guoye;BAI Qin;CHEN Ning;LIU Ke;CHANG Jing;JIANG Wei(Changchun Institute of Biological Products in Co.,Ltd.,Changchun 130000,Jilin Province,China;不详)

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130000 [2]南京久诺科技有限公司,江苏南京210011 [3]南京利泰尔药业有限公司,江苏南京211153 [4]北京福元医药股份有限公司,北京100000

出　　处：《中国生物制品学杂志》2024年第12期1529-1536,共8页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划(202102024206YY)。

摘　　要：空调系统应为药品生产提供持续稳定的生产环境,满足药品生产工艺的动态需求。通过对洁净空调系统进行专项合规性改造,可提高洁净环境运行稳定性,优化冬季洁净区温湿度控制,降低生产过程中污染与交叉污染风险,确保洁净环境符合现行GMP及WHO合规性的要求。本次需改造的长春生物制品研究所有限责任公司疫苗灌装车间建造时间较早,虽经过局部改造和调整,但仍发现多项空调系统相关风险。因此,本文结合质量源于设计(Quality by Design,QbD)的理念,应用风险分析工具对该车间的空调系统合规性改造方案进行设计,贯穿于技术方案可行性论证、改造实施、系统调试、验证等改造全过程,以期提高改造车间洁净环境合规的可靠性及洁净空调系统运行的稳定性,同时解决北方地区疫苗车间冬季制冷降温的行业难题,降低项目改造建设投入成本及洁净空调系统的运行维护成本。Air conditioning system should provide a continuous and stable production environment for drug production and meet the dynamic needs of drug production process.Through special compliance modifications of clean air conditioning system,the operation stability of clean environment can be improved,the temperature and humidity control in clean area in winter can be optimized,the risk of pollution and cross contamination in production process can be reduced,and the clean environment can be ensured to meet the current GMP and WHO compliance requirements.The vaccine filling workshop to be renovated this time in Changchun Institute of Biological Products was built earlier.Although it has been partially renovated and adjusted,many risks related to air conditioning system were found.Therefore,combining the concept of Quality by Design(QbD),this paper applies risk analysis tools to design the air conditioning system compliance renovation scheme of the workshop,throughout the entire process of feasibility study,renovation implementation,system debugging and verification of technical solutions,so as to improve the compliance and reliability of clean environment and the operation stability of clean air conditioning system in the renovated workshop,solve the industry problem of winter cooling in vaccine workshops in northern region,and reduce the investment cost of project renovation and construction,as well as the operation and maintenance cost of clean air conditioning system.

关 键 词：质量源于设计 风险分析 疫苗灌装车间 空调系统 

分 类 号：R18[医药卫生—流行病学]