摘要
目的:评估《化妆品生产质量管理规范检查要点及判定原则》(以下简称《检查要点》)实施后广州市化妆品生产许可现场核查的情况,分析企业在适应新规过程中的主要挑战,为提升行业质量管理水平提供科学依据。方法:基于2023年广州市617家化妆品生产企业的现场检查数据,采用描述性统计与归因分析法,重点研究缺陷项目的分布特征、高频违规条款的表现形式及其成因。结果:《检查要点》实施后,广州市化妆品生产许可核查不通过率达46.35%,主要问题集中在质量保证与控制、厂房设施与设备管理、物料与产品管理、生产过程管理四个方面。结论:广州市化妆品生产企业在新规实施初期面临较大合规压力,现场检查中暴露出质量体系运行不规范、生产条件与管理水平不足等突出问题。企业需加强质量管理体系建设和硬件投入,监管部门则应优化分级分类监管机制、强化行业引导和信息公开。
Objective:This study evaluates the status of on-site licensing inspections for cosmetic manufacturers in Guangzhou following the implementation of the Inspection Key Points and Determination Principles for Cosmetic Good Manutacturing Practices(hereinatter referred to as the Inspection Key Points).It further analyzes the main challenges faced by manutacturers in complying with the new requirements and provides evidence-based recommendations for improving quality management in the cosmetic industry.Methods:On-site inspection data from 617 cosmetic manufacturers in Guangzhou in 2023 were analyzed using descriptive statstics and root cause analysis.The study focused on the distribution of deficiency items,the occurrence patterns of high-frequency non-compliance clauses,and their underlying causes.Results:The failure rate of licensing inspections reached 46.35%after the new regulatons took effect.Most deficiencies were concentrated in four areas:quality assuranca and control,facility and equipment management,matarial and product management,and production process management.Conclusion:In the initial stage of the new regulaton,cosmetic manufacturers in Guangzhou faced substantial compliance pressure.On-site inspections revealed systemic weaknesses,including inconsistent quality management system operations,substandard production conditions,and inadequate management practices.To address these issues,manufacturers should strengthen their quality management systems and invest in inftrastructure improvements,while regulatory authorities should opfimiza tered and categorized supervision mechanisms,provide stronger industy guidance,and enhance informafon tansparency.
作者
何羡霞
胡树文
陈晓丽
姜志辉
HE Xian-xia;HU Shu-wen;CHEN Xiao-li;JIANG Zhi-hui(Guangzhou Center for Food and Drug Evaluation;Department of Pharmacy,General Hospital of Southern Theater Command of PLA)
出处
《中国食品药品监管》
2026年第2期143-148,共6页
China Food & Drug Administration Magazine
基金
广州市校(院)企联合资助项目(2024A03J0644)。
关键词
化妆品生产
质量管理
现场检查
检查要点
缺陷分析
cosmetic manufacturing
quality management system
on-site inspection
inspecton key points
deficiency analysis
