疫苗生产企业GMP跟踪检查情况分析

目的  通过对国内多家疫苗生产企业进行GMP跟踪检查，分析缺陷项，评价国内疫苗生产企业的GMP管理现状。方法  按照国家食品药品监督管理总局（国家总局）药品化妆品监管司的年度检查计划，2016年国家总局食品药品审核查验中心派出检查员对36 家疫苗企业进行了跟踪检查 。结果  检查共发现421条缺陷，包括主要缺陷38条，一般缺陷383条。结论  国内疫苗生产企业基本按照GMP要求执行，管理尚存在不足，企业还应不断提升质量管理能力，确保疫苗质量。

Situation analysis of GMP follow-up inspection in vaccine manufacturers

Objective  To evaluate current situation of GMP management in domestic vaccine manufacturers through GMP follow-up inspections and analysis of observations. Methods  According to the yearly inspection plan by Department of Drug and Cosmetics Supervision in China Food and Drug Administration (CFDA), inspectors from Center for Food and Drug Inspection in CFDA were assigned to perform follow-up inspections at 36 vaccine manufacturers in 2016. Results  The inspections observed a total of 421 defects, including 38 major defects and 383 minor defects. Conclusion  In general, domestic vaccine manufacturers implement the requirement of GMP, but management still needs improvement. Manufacturers should continue to raise quality management ability to ensure the vaccine quality.