摘要
目的:为提高申报药品生产许可证(B证)的药品上市许可持有人质量管理水平,切实履行其对药品质量安全的职责提供参考。方法:对30家申报核发药品生产许可证B证单位的检查报告及发现问题进行统计汇总,分析该类企业存在的主要共性问题并提出建议。结果与结论:对30家药品生产许可证B证检查发现的260条缺陷进行梳理,研究发现相关企业不同程度地在机构与人员配备、质量管理体系建设、体系运行文件记录等方面存在问题。建议上市许可持有人构建有效管控产品风险的机构与人员基础,建设覆盖药品全生命周期的质量管理体系,关注生产的异常情况,切实履行好职责。
Objective: Analyze the implementation of the "Good Manufacturing Practices for Pharmaceutical Production"(2010 Edition) by Guangdong pharmaceutical manufacturers from 2018 to 2020 and the problems found in follow-up inspections, and provide references for regulatory authorities in formulating annual follow-up inspection plans and adopting regulatory measures. Pharmaceutical manufacturers implement GMP to provide technical guidance. Method:Statistically summarize the inspection reports and problems found by 30 units that have applied for the issuance of the B-certificate of the drug production license,analyze the main problems existing in this type of enterprise, and make recommendations. Results and conclusions: After comprehensively sorting out and categorizing the 260 defects found in the on-site inspection of 30 drug production license B certificate applicants, it was found that related enterprises have varying degrees of organization and staffing, quality management system construction, and imperfect system operation documents. The author classifies and introduces the common problems found in the inspection. It is recommended that all drug marketing authorization holders establish institutions and personnel that can effectively control drug quality risks, cover the entire life cycle of drug quality management systems, continue to pay attention to abnormal situations in actual production activities, and earnestly carry out the relevant parties related to product quality. Control responsibilities.
作者
招伟汉
江映珠
谢正福
邹毅
庞精聪
Zhao Weihan;Jiang Yingzhu;Xie Zhengfu;Zou Yi;Pang Jingcong(Center for Evaluation and Certification,Guangdong Drug Administration,Guangzhou 510080,China)
出处
《广东化工》
CAS
2021年第15期98-99,共2页
Guangdong Chemical Industry
基金
广东省药品监督管理局科技创新项目(2021TDZ07)。
关键词
药品上市许可持有人
药品生产许可证
检查
问题
分析
drug marketing authorization holder
pharmaceutical production license
inspection
issues
analysis
