摘要
介绍偏差管理的相关概念和实施步骤,分析我国制药企业偏差管理的现状和原因,阐述解决问题的关键。结论:目前我国药品生产的偏差管理还处于起步阶段,应该让制药企业充分认识到偏差管理的意义,将偏差管理融入到质量保证体系中去。
The status of deviation management of drug manufacturing was elucidated after introduction of relative concepts and implementation steps,especially describe the solution.Conclusion：Now the deviation management of drug manufacturing is still in its infancy.Pharmaceutical companies should fully realize the significance of deviation management.Deviation analysis is indispensable in quality assurance system during drug production.
关键词
偏差管理
药品生产
GMP
意义
Deviation management
Drug manufacturing
GMP
Significance
