2023年广州市化妆品生产许可现场检查问题分析与监管对策研究OA
Analysis of Issues in On-Site Inspections for Cosmetic Production Licensing in Guangzhou in 2023 and Research on Regulatory Countermeasures
目的 为企业和监管部门改进化妆品生产许可现场检查工作提供依据.方法 统计 2023 年广州市 617 家化妆品生产企业的生产许可现场检查数据,参考《化妆品生产质量管理规范检查要点及判定原则》,按缺陷项目级别(关键项目、重点项目、一般项目)分类梳理问题,结合具体条款和表现,分析生产过程中存在的主要问题与风险点.结果 现场核查不通过企业 286 家次,占比 46.35%,其中缺陷条款主要集中于重点项目(2340 次,56.60%),一般项目(1581 次,38.24%),关键项目虽占比低(213 次,5.15%),但风险严重,需重视.现场检查不通过的主要问题包括原料合规性缺陷、生产过程管理失控、质量管理体系执行不足及物料管理不规范等.结论 广州市化妆品生产企业需强化质量管理体系建设,优化生成过程控制及加强硬件设施与环境管控;监管部门需分级分类精准监管,完善法规宣贯与行业协会共治,共同提升行业规范性与安全性.
Objective To provide a basis for improvement the on-site inspections work for cosmetic production licensing for both enterprises and regulatory authorities.Methods The on-site inspection data for production licensing of 617 cosmetic manufacturing enterprises in Guangzhou in 2023 were statistically analyzed.Referring to the Key Points for Inspection and Principles for Determination for Cosmetic Production Quality Management Standards″,issues were categorized and sorted out according to the level of defective items(critical items,key items,general items).The main problems and risk points in the production process were analyzed based on specific clauses and manifestations.Results A total of 286 enterprises(46.35%)failed the on-site inspections.The defective clauses were primarily concentrated in key items(2 340 times,56.60%)and general items(1 581 times,38.24%).Although critical items accounted for a low proportion(213 times,5.15%),the risks were severe and required attention.The main issues leading to inspection failure included defects in raw material compliance,lack of control in production process management,insufficient implementation of the quality management system,and non-standard material management.Conclusion Cosmetic manufacturing enterprises in Guangzhou need to strengthen the construction of their quality management systems,optimize production process control,and enhance hardware facility and environmental controls.Regulatory authorities should carry out precise hierarchical and classified supervision,improve the communication and implementation of regulations,and promote co-governance with industry associations,collectively working to enhance industry standardization and safety.
何羡霞;姜志辉;胡树文;赵伟
广东省广州市食品药品审评中心,广东 广州 510140中国人民解放军南部战区总医院,广东 广州 510010广东省广州市食品药品审评中心,广东 广州 510140中国人民解放军南部战区总医院,广东 广州 510010
医药卫生
化妆品生产广州市现场检查质量管理
cosmetic productionGuangzhouon-site inspectionquality management
《中国药业》 2026 (6)
18-21,4
广东省广州市科技计划项目[2024A03J0644].
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