湖北原料药GMP认证中发现的主要缺陷及建议-中国药事.PDF

1264 ·质量管理· 湖北省原料药GMP认证中发现的主要缺陷及建议 * 孙煜，吕思伊 ，魏曼 （湖北省食品药品监督管理局技术审评核查中心，武汉 430071） 摘要 目的： 为全面理解原料药GMP认证相关标准，提高生产企业对原料药生产规范的认识和检查员的 检查水平。方法：对2016年至2017年湖北省原料药现场检查中主要缺陷进行统计分析，对GMP认证中主 要缺陷项目进行分类总结。结果与结论：通过共性问题，结合原料药产品的本身特点，建议加强各岗位 操作人员培训，落实培训效果；合理设计厂房，加强硬件系统的改造；严格把关物料，做好溶剂回收工 作；注重细节，有针对性做好确认与验证工作；文件管理系统化，记录填写规范化；引入风险管理，贯 彻执行生产全过程管理；重视变更和偏差管理，提高质量意识；建立职业化检查员队伍。 关键词： 原料药；GMP认证；主要缺陷项目 R95 A 1002-7777(2018)09-1264-07 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.09.018 Main Defects and Suggestions on GMP Certification of Active Pharmaceutical Ingredients in Hubei Province * Sun Yu, Lv Siyi , Wei Man (Center for Evaluation and Inspection, Hubei Food and Drug Administration, Wuhan 430071, China) Abstract Objective: To fully understand the relevant standards for good manufacturing practice (GMP) certification of active pharmaceutical ingredients (API) in order to improve the understanding of the production standards of API of enterprises and the level of inspectors. Methods: The main defects of on-site inspection of API of Hubei Province from 2016 to 2017 were statistically analyzed, and the main defects in GMP certification were classified and summarized. Results and Conclusion: According to the common problems combined with the characteristics of API, it is recommended to strengthen the training of operators in each position and to implement the training results; to rationally design the workshop and to strengthen the transformation of the hardware system; to strictly control the materials and do a good job of solvent recovery; to pay attention to details and to do a good job of targeted confirmation and verification; to systemize the document management and to standardize the record; to introduce risk management and to implement the whole production process management; to pay attention to change and deviation management