HACCP法确定冻干粉针剂生产系统检查重点的探讨

目的 探索风险管理在药品GMP认证中的应用,用风险管理的原则指导药品GMP认证现场检查.方法 用风险管理工具危害分析和关键控制点（HACCP）的方法,确定冻干粉针剂生产系统现场检查的重点,并列出检查清单.结果与结论 运用风险管理原则,可以合理地分配资源,使药品GMP认证现场检查更具科学性、针对性.

Defining Inspection Key Points in Freeze-dried Vials Production System with HACCP Method

Objective To explore the application of risk management in pharmaceutical GMP certification, and instruct site inspection of pharmaceutical GMP with risk management principle. Methods The key points of site inspection in freeze-dried vials production system were defined with the risk management tool-hazard analysis and critical control points （HACCP）, and the inspection list was made. Results and Conclusion More reasonable resource distribution will be achieved with risk management principle, which may contribute to the site inspection of pharmaceutical GMP certification with improved scientificity and targetablility.