辽宁省无菌药品生产企业质量管理调查与分析  

Investigation and Analysis of Quality Management in Sterile Drug Manufacturing Enterprises in Liaoning Province

作　　者：王璐 王晓 宋姝 WANG Lu;WANG Xiao;SONG Shu(Liaoning Center for Drug Evaluation&Inspection,Shenyang,Liaoning,China 110016)

机构地区：[1]辽宁省药品审评查验中心,辽宁沈阳110016

出　　处：《中国药业》2025年第4期5-10,共6页China Pharmaceuticals

摘　　要：目的 为无菌药品生产企业持续完善质量管理体系提供指导和建议。方法 统计并分析2021年1月至2023年6月辽宁省无菌药品生产企业《药品生产质量管理规范》符合性检查一次性通过情况及缺陷项目的分布情况及其风险,提出完善相关质量体系的意见和建议。结果 共129家企业参加检查,127家(98.45%)一次性通过。共发现缺陷项目1 229项,其中严重缺陷2项(0.16%),主要缺陷48项(3.91%),一般缺陷1 179项(95.93%)。缺陷最多的章节为质量控制与质量保证、文件管理;严重缺陷风险点主要体现在记录真实性、关键人员履职等方面,主要缺陷风险点主要体现在质量控制与质量保证、确认与验证、文件管理章节;一般缺陷分布于166条条款,其中117条条款发现多次缺陷。结论 企业应提升人员无菌意识、建立风险思维方式,提升文件系统性、加强记录的合理性及可追溯性;加强设施设备管理、源头控制污染,强化验证管理、提升持续工艺确认理念,进一步提高无菌药品生产质量管理水平。Objective To provide guidance and suggestions for sterile drug manufacturing enterprises to continuously improve their quality management systems.Methods The one-time pass cases of inspection for conformity,the distribution of defect items and their risks based on the Good Manufacturing Practice of sterile drug manufacturing enterprises in Liaoning Province from January 2021 to June 2023 were summarized and analyzed,and the opinions and suggestions for improving the relevant quality system were proposed.Results A total of 129 enterprises participated in the inspection,and 127(98.45%)passed at one time.A total of 1229 defective items were identified,including two severe defects(0.16%),48 major defects(3.91%),and 1179 general defects(95.93%).The chapters with the most defects were the quality control,quality assurance,and document management.The risk points of serious defects were reflected in the authenticity of records,the performance of key personnel,etc;the risk points of main defects were reflected in the chapters of quality control,quality assurance,confirmation,verification,and document management.The general defects involved 166 items,of which 117 were found to involve multiple defects.Conclusion Enterprises should enhance personnel′s sterile awareness,establish a risk thinking approach,improve document systematization,strengthen the rationality and traceability of records,strengthen facility and equipment management,control pollution at the source,enhance verification management,improve the concept of continuous process confirmation to further improve the quality management level of sterile drug production.

关 键 词：无菌药品 药品生产质量管理规范 风险 

分 类 号：R95[医药卫生—药学]