摘要
旨在了解美国食品药品监督管理局药品cGMP检查中关于数据完整性的关注重点和检查趋势,从而为我国制药企业在数据管理方面提供改进思路。通过对比各国家/组织发布的数据完整性指南,统计分析2014—2019年FDA对美国境外企业发布的245封药品cGMP警告信,重点解析涉及数据完整性的172封警告信,归纳警告信中经常发生的数据完整性缺陷项目。近五年来,FDA对境外企业发布的药品cGMP警告信数量显著增加,检查力度和检查范围逐渐增加,警告信中频繁提及数据完整性缺陷,数据完整性问题突出。出现频次较高的前三项数据完整性缺陷依次是实验室数据维护不当、实验室系统控制不足、主生产和批生产记录控制不足。企业可应用质量风险管理工具有效实现数据管理,将数据完整性纳入质量管理体系,从人、机、料、环、法五个层面对其进行控制。
To understand the focus and inspection trend of data integrity in Current Good Manufacturing Practice(cGMP)international inspection by FDA,and to provide references for Chinese pharmaceutical enterprises in data management.METHODS:Based on the comparisons of data integrity guidelines issued by different countries/organizations,245 drug cGMP warning letters issued to foreign enterprises by FDA from 2014 to 2019 were analyzed statistically,emphasizing on the analysis of 172 warning letters concerning data integrity,and summarizing the frequent defects.Over the past five years,the number of drug cGMP warning letters issued by FDA to foreign enterprises increased significantly,and the intensity and scope of international inspection has become larger.Data integrity defects are frequently mentioned in warning letters so that data integrity issue is prominent.The top three data integrity defects with high frequency are the improper maintenance of laboratory data,inadequate control of laboratory system,and inadequate control of main production and batch production records.Enterprises can apply quality risk management to effectively implement data management,incorporate data integrity into the quality management system,and control it from five levels:human,machine,material,environment and regulation.
作者
周清萍
周娜
梁毅
Zhou Qingping;Zhou Na;Liang Yi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198)
出处
《化工与医药工程》
2020年第1期62-68,共7页
Chemical and Pharmaceutical Engineering
关键词
警告信
数据完整性
数据管理
质量风险管理
warning letter
data integrity
data management
quality risk management
