甘肃省疫苗、血液制品生产企业巡查问题分析与思考OA

Objective:This study aims to review the current status of the vaccine and blood product industry and quality management in Gansu Province,identify common problems and major risk points in the production of vaccines and blood products,and standardize and improve the quality management of these products.Methods:Statistically analysis was performed on the inspection status and defective identified during inspections of vaccine and blood product manufacturers in Gansu Province conducted by the National Medical Products Administration from 2021 to 2025.The risk points found in the inspections were discussed and analyzed.Results and Conclusion:The inspection defects of vaccine and blood product manufacturers in Gansu Province are concentrated in key areas such as quality control and assurance,document management,qualification and validation,production management under the Good Manufacturing Practice(GMP),and its appendix Sterile Drugs.Inspection agencies and relevant enterprises should pay special attention to these aspects during routine supervision and inspection as well as in the operation of their quality management system.