对迁建疫苗生产企业监管策略的探讨

目的 依据《中华人民共和国药品管理法》和《药品生产质量管理规范(2010年修订)》等法规,对迁建疫苗生产企业进行检查并提出监管策略.方法 对上海一家迁建企业的疫苗生产车间进行生产许可证检查、药品注册研制现场核查、药品GMP认证检查、药品GMP跟踪检查和药品GMP飞行检查.结果 对生产场地变更后疫苗的持续稳定性考察结果显示,各项目检定均合格.但是,发现生产许可证检查2项问题、药品注册研制现场核查3项问题、药品GMP认证检查15项缺陷、药品GMP跟踪检查2项缺陷、药品GMP飞行检查1项缺陷.结论 对迁建企业的变更控制是监管的重点内容之一.监管部门应继续加大力度并制定针对性策略,以达到促进企业生产安全有效疫苗、控制潜在风险的目的.

Discussion on regulatory strategy for relocated and reconstructed vaccine manufacturers

Objective To inspect a relocated vaccine manufacturer and propose regulatory strategies according to the Drug Administration Law of the People's Republic of China,Good Manufacturing Practice for Drugs (2010 Revision) and other laws and regulations.Methods A relocated vaccine manufacturer in Shanghai was investigated in terms of drug production license,on-site drug registration development,drug GMP certification,GMP follow-up and unannounced inspection.Results The continuous stability investigation of vaccines produced after production site change showed that all items had qualified.However,2 issues on drug license inspection,3 issues on on-site drug registration development inspection,15 defects on GMP certification inspection,2 defects on GMP follow-up inspection and 1 defect on unannounced inspection were found.Conclusions Change control of relocated manufacturers is one of the important contents of regulation.Regulatory authorities should continue to intensify efforts and develop intended strategy,in order to achieve the goal of promoting manufacturers to produce safe,effective vaccines and keep potential risks under control.