山东省生物制品生产质量管理风险分析与探讨  

Risk Analysis and Discussion on Production Quality of Biological Products in Shandong Province

作　　者：胡敬峰 宋凯 冯巧巧 樊红延 周勇 Hu Jingfeng;Song Kai;Feng Qiaoqiao;Fan Hongyan;Zhou Yong(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)

机构地区：[1]山东省食品药品审评查验中心,济南250014

出　　处：《中国药事》2023年第9期1028-1032,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:了解山东省生物制品产业和质量管理现状,识别生物制品生产中存在的共性问题和主要风险点,规范生物制品的生产质量管理。方法:统计分析2019-2021年山东省生物制品生产检查情况和缺陷项目,对检查发现的风险点进行探讨分析。结果与结论:山东省生物制品生产检查缺陷集中在确认与验证、质量控制与质量保证、无菌保证、生产管理等方面,企业应在质量管理体系运行过程中予以重点关注。Objective:To understand the quality management situation of biological products industry and quality management in Shandong Province,to discern the common observed deficiencies and the main risks points in the production of biological products,and standardize the Good Manufacturing Practices of biological products.Methods:Statistical analysis of the inspection situation and defect items of biological products manufacturing enterprises from 2019 to 2021 in Shandong Province.Discuss and analyze the risk points of biological products found in the inspection.Results and Conclusion:The inspection defects of biological products production inspection in Shandong Province focus on qualification and validation,quality control and quality assurance,sterility assurance and manufacturing management and other aspects,it is recommended that enterprises should pay more attention to them in the quality management system operating process.

关 键 词：生物制品 药品生产质量管理规范 检查 缺陷项目 风险分析 

分 类 号：R95[医药卫生—药学]