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| OOS系统、偏差管理系统和CAPA系统比较 | |
| 引用本文： | 陈军丽,高海燕,丁恩峰,郭娅楠.OOS系统、偏差管理系统和CAPA系统比较[J].医药工程设计,2010,31(5):17-20. |
| 作者姓名： | 陈军丽 高海燕 丁恩峰 郭娅楠 |
| 作者单位： | 1. 石家庄第三医院制剂科,河北石家庄,050031 2. 石药集团恩必普药业有限公司,河北石家庄,050031 3. 英国施达化学集团公司中国代表处,河北石家庄,050031 4. 北京赛铭医药科技有限公司,北京,100054 |
| 摘 要： | 制药企业为了保证产品质量,必须确保质量管理体系正常运行。但是,由于质量系统组成的庞大和复杂性,每个制药企业的质量保证系统都处于波动变化中。因而,制药企业针对质量系统的关键要素,需要持续地,定期地对质量系统进行维护和纠正。在GMP质量管理学发展过程中,偏差管理系统、OOS系统和CAPA系统是不同历史阶段出现的质量系统维护工具。为了帮助制药企业更好的理解和应用这些工具,作者结合自己的工作经验和相关指南、著作,对这3个系统进行比较和分析,并系统研究各自特点和差异。 |
| 关 键 词： | 质量 GMP OOS 偏差 CAPA QBD |
Comparison of Systems of OOS, Deviation Management and CAPA |
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| Chen Junli,Gao Haiyan,Ding Enfeng,Guo Yanan.Comparison of Systems of OOS, Deviation Management and CAPA[J].Pharmaceutical Engineering Design,2010,31(5):17-20. | |
| Authors: | Chen Junli Gao Haiyan Ding Enfeng Guo Yanan |
| Institution: | 1. Shijiazhuang Pharma Group EBP Pharmaceutical Co.,Ltd Shijiazhuang,050031; 2. China Representative Office,Great Briton Shida Chemical Group Co. Shijiazhuang,050031; 3. Shijiazhuang No. 3 Hospital Shijiazhuang,050031; 4. Beijing Spring Pharma Tech Inc. Beijing,100054) |
| Abstract: | In order to keep acceptable quality of drugs,pharmaceutical enterprises must ensure the normal operation of quality system. However,in view of that quality system may be cumbersome and complex,the quality system in all pharmaceutical enterprises will be always changed. Then,continuous and periodical maintenance of quality system should be carried out with respect to the key elements in the system. In the development of GMP quality administration,all of deviation management system,OOS system and CAPA system,which appeared in different historic stages,are the maintenance tools of quality system. In order to help enterprises understand and apply these tools well,in this article,combined with work experiences and guides,these three tools were analyzed and compared in their characteristics and differences. |
| Keywords: | quality GMP OOS deviation CAPA QBD |
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