中国食品药品监管Issue(5)：136-143,8.DOI:10.3969/j.issn.1673-5390.2026.05.012
甘肃省疫苗、血液制品生产企业巡查问题分析与思考
Analysis and Reflection on Inspection Issues of Vaccine and Blood Product Manufacturers in Gansu Province
摘要
Abstract
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.关键词
疫苗/血液制品/巡查/药品生产质量管理规范/缺陷项目Key words
vaccines/blood products/inspection/Good Manufacturing Practice/defective items分类
医药卫生引用本文复制引用
孔丽亚,麻银林,贺学锋,刘晨鸣,胡闽..甘肃省疫苗、血液制品生产企业巡查问题分析与思考[J].中国食品药品监管,2026,(5):136-143,8.基金项目
甘肃省药品监督管理局药品科研项目(2024GSMPA059,2024GSMPA056) （2024GSMPA059,2024GSMPA056）
甘肃省市场监督管理局科技计划项目(SSCJG-ZH-A202408) （SSCJG-ZH-A202408）
