药品生产技术转移中质量管理的探讨  

Discuss the Quality Management in Drug Production Technology Transfer

作　　者：潘凯 张久锋 孙小咪 PAN Kai;ZHANG Jiufeng;SUN Xiaomi(Department of Drug,Cosmetics and Medical Device Supervision,Wujiang District Market Supervision Bureau,Suzhou City,Suzhou Jiangsu 215200,China;Department of Food Safety,Wujiang District Market Supervision Bureau,Suzhou City,Suzhou Jiangsu 215200,China;Director Office,Suzhou Inspection Branch of Jiangsu Drug Administration,Suzhou Jiangsu 215021,China)

机构地区：[1]苏州市吴江区市场监管局药品化妆品与医疗器械监管科,江苏苏州215200 [2]苏州市吴江区市场监管局食品安全科,江苏苏州215200 [3]江苏省药品监督管理局苏州检查分局局长室,江苏苏州215021

出　　处：《中国卫生标准管理》2024年第3期112-115,共4页China Health Standard Management

摘　　要：药品质量会受到较多因素影响,针对药品生产技术的有效性转移过程也不例外。转移药品生产技术,要充分研究产品质量的影响条件,关联我国药品生产技术转移的关键点,综合规避药品质量管理风险,强化药品生产技术转移的综合成效。文章首先进行药品生产技术转移基本概述;其次介绍药品生产技术转移质量管理相关问题;最后从规范管理人员与设备设施、科学管理物料和生产过程、有效进行质量控制、合理转移分析方法、及时构建监管机制几个方面深入说明并探讨药品生产技术转移的质量管理有效措施,不断优化质量管理方案,健全药品生产技术转移管理体系,目的是给相关研究带来条件支持。The quality of drugs will be affected by many factors,and the effectiveness transfer process of drug production technology is no exception.To transfer drug production technology,it is necessary to fully study the influence conditions of product quality,associate the key points of drug production technology transfer in China to comprehensively avoid the risk of drug quality management,and strengthen the comprehensive effect of drug production technology transfer.This paper first overviews the basic of drug production technology transfer,then introduces the drug production technology transfer quality management related issues,finally from the standard management personnel and equipment and facilities,scientific management materials and production process,effective quality control,reasonable transfer analysis,timely build supervision mechanism of deeply explain and discuss effective measures of quality management,constantly optimize the quality management scheme,improve the drug production technology transfer management system,the purpose is to bring conditional support to related research.

关 键 词：药品生产 技术转移 质量管理 物料和生产过程管理 监管机制 有效措施 

分 类 号：R927[医药卫生—药学]