摘要
文件作为GMP系统中的"软件",是GMP体系的保证,GMP文件的规范化管理是药品生产企业生产过程规范化管理的前提。本文从制药企业工作中的实际问题出发,探讨企业在GMP文件管理中的常见问题和解决方法。
As the software in GMP system, document is the guarantee to exert GMR The standardized management of GMP document is the prerequisite to administrate the production process in pharmaceutical enterprises in standardization. With the practical problems in the work in pharmaceutical enterprises, the usual problems in the management of GMP document and relevant solving methods were discussed in this article.
出处
《医药工程设计》
2007年第4期39-41,共3页
Pharmaceutical Engineering Design
关键词
GMP文件管理
management of GMP document