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| 药品生产质量保证体系的建立 | |
| 引用本文： | 许春阳,吴立文,李明斐. 药品生产质量保证体系的建立[J]. 生物技术通讯, 2004, 15(1): 98-101 |
| 作者姓名： | 许春阳 吴立文 李明斐 |
| 作者单位： | 1. 军事医学科学院生物工程研究所 2. 北京四环生物制药有限公司,北京,100071 3. 大连理工大学,管理学院,大连,116024 |
| 摘 要： | 以《药品生产质量管理规范》(GMP)为依据，运用“过程方法”、“管理的系统方法”和“层次分析”理论，以药品生产体系的增值链系统为线索，对药品生产质量管理中的工序控制、信息传递、各子系统间的关联和衔接进行分析，以流程图的形式表示，并将系统要素人、物、信息和程序控制标明，建立起质量保证体系。涵盖了系统的全部关键质量控制点，职责清晰、不易遗漏、便于控制和发现问题。解决了药品生产质量控制及GMP实施中的难点，是药品生产企业行之有效的质量管理的手段。 |
| 关 键 词： | 药品生产 质量保证体系 GMP 流程图 |
| 文章编号： | 1009-0002(2004)01-0098-04 |
The establishment of manufacturing quality assurance system for drugs |
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| XU Chun-yang ,WU Li-wen ,LI Ming-fei .School of Management,Dalian University of Technology,Dalian. The establishment of manufacturing quality assurance system for drugs[J]. Letters in Biotechnology, 2004, 15(1): 98-101 | |
| Authors: | XU Chun-yang WU Li-wen LI Ming-fei .School of Management Dalian University of Technology Dalian |
| Affiliation: | XU Chun-yang 1,WU Li-wen 2,LI Ming-fei 1 1.School of Management,Dalian University of Technology,Dalian116024,2.Beijing Sihuan Biopharmacy Company,Beijing100071,China |
| Abstract: | Using the theories of process method and management system method,and based on Good Manufacturing Prac-tices for drugs,the procedure control,the information transport and the branch system's connection of the manufacturing quality management for drugs were analysised and presented in the form of flow charts,and the quality assurance system were established.It is suggested that this system were effective to improve the manufacturing quality management level. |
| Keywords: | drugs manufacturing quality assurance system GMP flow chart |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |