质量量度在国内药品生产企业中的应用(1)
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。
关键词 质量量度 质量管理体系 药品质量 工艺性能
中图分类号：F406.2 文献标识码：C 文章编号：1006-1533(2016)23-0069-04
Application of quality metrics in Chinese pharmaceutical enterprises
BAO Minzhi1*， HU Tingxi2(1. Suzhou Teraypharm Inc.， Suzhou 215151， China； 2. School of International Pharmaceutical Business， China Pharmaceutical University， Nanjing 211198， China)
ABSTRACT 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 ......
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关键词 质量量度 质量管理体系 药品质量 工艺性能
中图分类号：F406.2 文献标识码：C 文章编号：1006-1533(2016)23-0069-04
Application of quality metrics in Chinese pharmaceutical enterprises
BAO Minzhi1*， HU Tingxi2(1. Suzhou Teraypharm Inc.， Suzhou 215151， China； 2. School of International Pharmaceutical Business， China Pharmaceutical University， Nanjing 211198， China)
ABSTRACT 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 ......
您现在查看是摘要页，全文长 4222 字符。