药品注册生产现场核查助推药品研发全面融入GMP

目的 指明药品研发阶段融入药品GMP管理的必要性及重要性.方法 介绍了药品注册生产现场核查概况,从人员、设施、设备、原辅料和包装材料、样品批量生产过程、质量控制等方面,分析了药品注册生产现场核查的施行对国内生产企业将药品研发纳入GMP体系的促进作用.结果与结论 我国药品生产企业应将药品研发全面融入GMP管理体系之中,而药品注册生产现场核查可以很好地促进药品研发的规范性及GMP的符合性.

On-site Inspection for Pharmaceutical Registration Integrates Drug Research and Development in to GMP System

Objective To indicate the necessity and significance for pharmaceutical manufacturers to integrate pharmaceutical research and development （R＆D） into the whole GMP system. Methods The onsite inspection and study audit for pharmaceutical registration was introduced, and the acceleration function of it on integrating R＆D into GMP was analyzed on aspects of personnel, facilities, raw materials and excipients, packaging materials, mass production process of samples, quality control and so on. Results and Conclusion Chinese pharmaceutical manufacturers should integrate drug R＆D into the whole GMP system, and the on-site inspection and study audit for pharmaceutical registration has an important role for achieving it.