制药企业质量管理体系的探讨

Discussion of quality management system in pharmaceuticals manufacture

有效的质量管理体系对于保证药品的质量,确保人民群众的用药安全是非常重要的。在通过GMP认证之后,如何不断地完善和改进既有的质量管理体系是目前制药企业普遍面临的重要问题之一。本文分别从组织机构和员工培训、文件管理、质量管理程序及制度、验证等四个方面进行了探讨。

Effective quality management system is important in ensuring the quality of medicine and people＇s usage safety. How to improve the proposed quality management system after GMP certification is one of the most important questions the pharmaceutical manufacturers facing. The article discusses the above problem in the following four aspects： organization chart and staff training, document management system, management procedure and validation management.