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。
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.
出处
《医药工程设计》
2010年第5期17-20,共4页
Pharmaceutical Engineering Design
