河南省药品生产企业《药品生产质量管理规范》符合性检查情况分析  

GMP Compliance Inspection of Drug Manufacturers in Henan Province

作　　者：李磊 党明安 郭海波 LI Lei;DANG Ming'an;GUO Haibo(Henan Center for Food and Drug Evaluation and Inspection,Zhengzhou,Henan,China 450000)

机构地区：[1]河南省食品药品审评查验中心,河南郑州450000

出　　处：《中国药业》2023年第11期21-26,共6页China Pharmaceuticals

摘　　要：目的规范药品生产企业安全、合规生产,为药品监督管理部门制订监管措施提供参考。方法统计并分析河南省2020年5月至2021年11月在对172家次高风险药品生产企业《药品生产质量管理规范》(GMP)符合性检查中发现的缺陷项目,并有针对性地提出改进措施与建议。结果共发现缺陷项目1028项,其中主要缺陷26项,一般缺陷1002项,严重缺陷0项。涉及缺陷条款1045条次,主要分布于质量控制与质量保证(19.23%)、文件管理(17.89%)、设备(17.03%)、确认与验证(6.03%)、物料与产品(5.93%)、附录中的无菌药品(5.93%)。生物制品、无菌药品(注射剂、滴眼剂、眼膏剂、无菌原料药)、毒性饮片生产企业分别发现缺陷项目62项、682项、269项,分别涉及缺陷条款66条次、687条次、270条次。结论在执行GMP过程中,药品生产企业应强化质量控制与质量保证体系的管理,建立并完善文件管理体系,加强全过程培训,做好厂房设施设备的日常使用及维护;药品监督管理部门应持续优化资源配置,提升科学监管能力。Objective To standardize the safety and compliance production of drug manufacturers,and to provide a reference for drug regulatory authorities to formulate regulatory measures.Methods The defective items found during the Good Manufacturing Practice(GMP)compliance inspection of 172 sub-high-risk drug manufacturers in Henan Province from May 2020 to November 2021 were collected and analyzed,and the targeted improvement measures and suggestions were proposed.Results A total of 1028 defective items were found,including 26 major defective items,and 1002 general defective items,without serious defective items.There were 1045 defect clauses involved,mainly distributed in quality control and assurance(19.23%),documentation management(17.89%),equipment(17.03%),confirmation and validation(6.03%),materials and products(5.93%),and Annex 1:sterile medicinal products(5.93%).A total of 62,682,and 269 defective items(involving 66,687,and 270 times,respectively)were found in the manufacturers of biological products,sterile drugs(injections,eye drops,eye ointments,sterile raw materials),and toxic decoction pieces respectively.Conclusion In the implement of GMP,drug manufacturers should strengthen the management of quality control and assurance systems,establish and improve document management systems,strengthen whole process training,and do a good job in the daily use and maintenance of factory facilities and equipment.The drug regulatory authorities should continuously optimize the allocation of resources and improve the ability of scientific supervision.

关 键 词：《药品生产质量管理规范》 高风险药品生产企业 符合性检查 缺陷项目 河南省 

分 类 号：R95[医药卫生—药学]