张书卉

    摘 要 综合分析近一年江苏省B类药品生产许可证核发检查中发现的问题，将主要风险点归纳为生产管理、文件管理、质量保证、机构与人员等4个方面，提出对策和建议，实现促进研发机构型上市许可持有人提升质量管理水平、持续合法合规的目的。

    关键词 B类药品生产许可证 研发机构 上市许可持有人 风险点

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2022)03-0063-04

    Analysis of the common problems in the issuance and inspection of pharmaceutical production license of class B

    ZHANG Shuhui

    (the Certification and Evaluation Center of Jiangsu Food and Drug Administration， Nanjing 210002， China)

    ABSTRACT Through a comprehensive analysis of the problems found in the issuance and inspection of pharmaceutical production license of class B in Jiangsu Province in the past year， the main risk points are summarized into four aspects： production management， document management， quality assurance， institution and personnel， and the relative countermeasures and suggestions are proposed so as to achieve the purpose of promoting R&D institution-type listing license holders to improve their quality management level and to continuously comply legal regulations.

    KEy wORDS pharmaceutical production license of class B； R&D institution； marketing authorization holder； risk points ......