质量量度在国内药品生产企业中的应用  

Application of quality metrics in Chinese pharmaceutical enterprises

作　　者：包敏芝 胡廷熹[2] 

机构地区：[1]苏州特瑞药业有限公司,苏州215151 [2]中国药科大学国际医药商学院,南京211198

出　　处：《上海医药》2016年第23期69-72,78,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：本文借鉴FDA质量量度指南草案,结合中国2010版药品生产质量管理规范(GMP)要求以及企业现状,总结以往质量管理的经验,提出了用于衡量国内药品生产企业中药品质量和工艺性能的质量量度指标及其计算方法和考核评估频率建议。The quality metrics items for the measurement of the quality and process performance of drugs produced in Chinese Pharmaceutical enterprises and suggestions on the approaches and frequency for the calculation and evaluation of quality metrics were proposed by referring to Request for Quality Metrics Guidance for Industry（FDA draft） and the requirements of Good Manufacturing Practice（GMP, China, 2010） and based on the current situation of Chinese pharmaceutical enterprises combined with the writer＇s experiences in quality management.

关 键 词：质量量度 质量管理体系 药品质量 工艺性能 

分 类 号：R95[医药卫生—药学]