Discussion on the Management of Pharmaceutical Changes in Seasonal Influenza Vaccine Strain
Every year,the World Health Organization(WHO)monitors influenza strains around the world and provides corresponding guidelines to guide the production of seasonal influenza vaccines for the year.Vaccine manufacturers produce seasonal influenza vaccines every year based on influenza strains recommended by the WHO.The changes of influenza vaccine strains involve multiple stages,including the influenza monitoring system,data collection and analysis,vaccine strain recommendation,screening and distribution of similar/seed strains,seed lot amplification and preparation,vaccine production,testing,distribution,and vaccination.How enterprises manage the change of influenza vaccine strains is crucial to the safety,efficacy,and quality control of vaccines.This paper discusses the domestic and international regulatory requirements for influenza strains changes,the current status of domestic influenza strain changes,and the pharmaceutical work carried out for strain changes.The aim is to guide the change management of influenza strains in enterprises and to provide references for the change management of other vaccine strains.
万方数据
维普
