Generation Pathways and Control Strategies of Visible Particles in Injections
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.
万方数据
维普
