污染控制策略在无菌药品参数放行中的应用探讨  

Application of contamination control strategy in parametric release for sterile drugs

作　　者：汤平 蒋芙蓉 陈超 申景丰 李长林 TANG Ping;JIANG Fu-rong;CHEN Chao;SHEN Jing-feng;LI Chang-lin(Hunan Kelun Pharmaceutical Co.,Ltd.,Yueyang Hunan 414100;Hunan Center for Drug Evaluation and ADR Monitoring,Changsha 410003;Hunan Medical Products Administration,Changsha 410003)

机构地区：[1]湖南科伦制药有限公司,湖南岳阳414100 [2]湖南省药品审评与不良反应监测中心,长沙410003 [3]湖南省药品监督管理局,长沙410003

出　　处：《中南药学》2024年第7期1957-1962,共6页Central South Pharmacy

摘　　要：目的探讨污染控制策略在无菌药品参数放行中的应用。方法通过对国内外参数放行相关法规和实践的总结分析,以及对污染控制策略实施要点的整理归纳,总结污染控制策略在参数放行中的应用方法。结果通过对污染控制策略的充分应用,建立了全面的无菌药品参数放行的微生物污染控制体系,确保生产过程微生物污染控制有效。结论运用污染控制策略搭建参数放行的微生物污染防控体系,管控过程要素,能够确保产品质量,最终实现参数放行。Objective To apply the contamination control strategy in parametric release for sterile drugs.Methods Based on the summary and analysis of relevant laws and practices of parametric release at home and abroad,as well as the implementation key points,the application of contamination control strategy in parametric release was summarized.Results The comprehensive microbial contamination control system for the for the parametric release of sterile drugs was established to ensure the effective microbial contamination control in the production process.Conclusion Application of contamination control strategy helps prevent contamination and control elements to ensure the quality.

关 键 词：参数放行 污染控制策略 无菌保证 

分 类 号：R95[医药卫生—药学]