重庆市原料药生产企业现场检查缺陷分析及优化建议

Defect Analysis in On-Site Inspection of API Manufacturing Enterprises in Chongqing and Optimization Suggestions

目的为原料药生产企业规范自身生产过程提供指导,并为现场检查的优化提供建议。方法依据《药品生产质量管理规范》(2010年版)及其附录要求,调取重庆市2019年至2021年原料药生产企业现场检查报告47份,统计并总结现场检查缺陷,并提出检查策略优化建议。结果共发现缺陷项目439条,其中主要缺陷项目35条,一般缺陷项目404条;缺陷项目涉及质量控制与质量保证(112条,25.51%),文件管理(76条,17.31%),设备(55条,12.53%),生产管理(27条,6.15%),物料与产品(40条,9.11%),确认与验证(58条,13.21%),机构与人员(13条,2.96%),厂房与设施(13条,2.96%)等。结论现场检查中发现重庆市原料药生产企业在数据完整性、变更控制、偏差管理、风险管理、验证等方面存在一定问题。对此,企业应规范自身生产行为,积极配合检查及整改,并加强风险管理;检查员参与现场检查前应结合企业整体水平、原料药品种、既往检查结论及整改落实情况,制订个体化现场检查方案,检查时注意关注企业偏差。从而进一步提高检查结果的真实性、准确性、可靠性,更有利于企业针对性改进自身缺陷。

Objective To provide the guidance for active pharmaceutical ingredient(API)manufacturing enterprises to standardize their manufacturing process,and to provide suggestions for optimizing the on-site inspection.Methods According to the requirements of the Good Manufacturing Practice(2010 Edition)and its appendix,47 on-site inspection reports of API manufacturing enterprises in Chongqing from 2019 to 2021 were collected.The defects in the on-site inspection were counted and summarized,and the suggestions for optimizing inspection were put forward.Results A total of 439 defective items were found,including 35 major defective items and 404 general defective items.Defective items involved the quality control and quality assurance(112 items,25.51%),document management(76 items,17.31%),equipment(55 items,12.53%),manufacturing management(27 items,6.15%),materials and products(40 items,9.11%),confirmation and verification(58 items,13.21%),institutions and personnel(13 items,2.96%),factories and facilities(13 items,2.96%)and so on.Conclusion During the on-site inspection,it is found that there are problems in the data completeness,changing control,deviation management,risk management,verification and other aspects of API manufacturing enterprises in this municipality.In this regard,in order to further improve the authenticity,accuracy and reliability of inspection results,and promote enterprises to improve their own defects accordingly,enterprises should regulate their own manufacturing behavior,actively cooperate with inspection,rectification,and strengthen the risk management.Before participating in the on-site inspection,inspectors should formulate the personalized on-site inspection plans based on the overall level of the enterprise,the variety of API,the previous inspection conclusions and the implementation of rectification.Besides,during the inspection,inspectors should pay attention to the deviations from the enterprises.