浅析医疗器械GMP对质量管理体系资源管理的要求

Opinion on the GMP Requirements on Resource Management within QMS of Medical Device Enterprises

对医疗器械生产质量管理体系中资源管理的重要内容以及GMP的相关要求进行了探讨,并介绍了我国医疗器械生产企业在资源管理方面的常见问题,以供相关企业在建立、完善生产质量管理体系和实施医疗器械GMP时参考。

The important issues and relative requirements of GMP on the management of resources within quality management system （QMS） of medical device enterprises arc discussed with the aim of providing reference for relative enterprises to build and improve their QMS and to implement GMP. Otherwise, those typical found problems in GMP inspections are also summarized.