注射剂生产过程中可见异物产生途径及控制策略

Generation Pathways and Control Strategies of Visible Particles in Injections

目的分析注射剂中可见异物的产生及控制措施,可见异物的检查方法,以降低注射剂中出现可见异物的风险。方法本文结合美国FDA《注射剂可见异物检查行业指南(草案)》和对药品生产企业的检查工作经验,从人、机、料、法、环等各方面,分析查找了注射剂药品生产过程中可见异物的主要产生途径、控制策略及可见异物的检测方法。结果与结论注射剂中可见异物是一项重要的质量控制指标,直接关系患者的安全,因此控制注射剂中可见异物尤为重要。

Objective To analyze the generation pathways,control measures and inspection methods of visible particles in injections,in order to reduce the resulted risks.Methods This article combines the US FDA’s“Industry Guidelines for Examination of Visible Particles in Injections(Draft)”and the experience in inspection work for pharmaceutical manufacturing enterprises,analyzes and searches for the main generation pathways,control strategies and detection methods of visible particles in the production of injections from various aspects such as personnel,machinery,materials,methods and environment.Results and Conclusion Visible particles in injections are an important quality control indicator that directly affects the safety of patients.Therefore,control of visible particles in injections is particularly important.