粉液双室袋产品质量风险分析与生产质量管理探讨  

Quality Risk Analysis and Production Quality Management of Powder-Liquid Dual-Chamber Bag Products

作　　者：胡小娟 白小琼 李珊 芮雪 胡士高 HU Xiaojuan;BAI Xiaoqiong;LI Shan;RUI Xue;HU Shigao(Center for Food and Drug Inspection of NMPA,Beijing 100076,China;Chongqing Center for Drug Evaluation and Inspection,Chongqing 401120,China;Anhui Center for Drug Evaluation and Inspection,Anhui Hefei 230051,China)

机构地区：[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 [3]安徽省药品审评查验中心,安徽合肥230051

出　　处：《中国医药导刊》2024年第10期969-974,共6页Chinese Journal of Medicinal Guide

基　　金：盖茨基金项目资助(粉液双室袋产品检查指南课题研究)。

摘　　要：目的:针对粉液双室袋产品的包装结构和工艺特点,识别该类产品生产质量主要风险点,为保障粉液双室袋产品安全性、有效性、质量可控性提供参考建议,促进相关生产企业生产质量管理水平提高。方法:通过分析国内外粉液双室袋产品的研究现状,基于粉液双室袋产品关键质量属性和工艺特点,结合现有法规及技术要求,剖析粉液双室袋产品在生产质量管理过程中存在的质量风险。结果:粉液双室袋产品在包装容器(材料)、焊接结构、灭菌干燥、无菌分装和无菌保证等方面存在特有风险。结论:相关企业应从加强包装容器(材料)研究、提升设施设备性能、强化生产工艺控制、提高无菌保证水平等方面制定策略,不断提高质量风险管理意识,持续提升粉液双室袋产品生产质量管理水平。Objective:Based on the packaging structure and process characteristics of powder-liquid dual-chamber bag products,to identify the main risk points of the production quality and provide reference suggestions to ensure the safety,effectiveness,and quality controllability of powder-liquid dual-chamber bag products,in order to promote the improvement of quality management level of related manufacturing enterprises.Methods:By reviewing the current research status globally,based on the critical quality attributes,production process characteristics and current laws,regulations and technical requirements,to analyze the quality risks in the production management process of powder-liquid dual-chamber bag products.Results:Powder-liquid dual-chamber bag products have distinct risks in packaging materials,welding structures,sterilization and drying processes,aseptic filling,and aseptic assurance.Conclusion:Enterprises should continuously improve the quality risk management awareness,and develop strategies to continuously improve the production quality management of powder-liquid dual-chamber bag products by strengthening research on packaging containers(materials),improving performance of facilities and equipments,optimizing control of manufacturing processes,and strengthening aseptic assurance level.

关 键 词：粉液双室袋产品 非PVC膜 弱焊 风险分析 质量管理 

分 类 号：R95[医药卫生—药学]