化妆品生产许可现场检查情况分析  

Analysis of on-site inspection of cosmetics production license

作　　者：王明慧 孙淼[2] 陈洪忠[2] 唐子安[2] 胡晓彤[2] 辛明 刘修齐 WANG Minghui;SUN Miao;CHEN Hongzhong;TANG Zian;HU Xiaotong;XIN Ming;LIU Xiuqi(Shandong Pharmaceutical Association,Jinan 250014,China;Center for Drug Evaluation and Certification,Shandong Food and Drug Administration,Jinan 250014,China)

机构地区：[1]山东省药学会,山东济南250014 [2]山东省食品药品监督管理局审评认证中心,山东济南250014

出　　处：《药学研究》2018年第10期615-617,共3页Journal of Pharmaceutical Research

摘　　要：目的分析山东省化妆品生产企业在实施《化妆品生产许可工作规范》过程中存在的问题,为今后制定个性化的监管对策和全面推进规范的实施提供技术参考。方法对111家次化妆品生产企业现场检查中发现的缺陷项目进行分析、统计,找出化妆品生产企业在执行质量体系中存在的主要、共性问题,分析成因,提出建议。结果与结论企业应提高自律意识,逐步建立完善的质量管理体系;注重物料和细节管理;确保培训的针对性和实效性,提高员工执行力。Objective To analysis the problems existing in the implementation of Specification for the licensing of cosmetics production in Shandong cosmetics production enterprises, provide technical reference for the formulation of personalized regulatory measures and the implementation of standardized implementation in the future.Methods The defective items which were found in the on-site inspection of 111 factory-times were collected in order to analyze the main and common problems and causes of quality system in the cosmetics manufacturing enterprises,and to put forward the corresponding suggestion.Results and Conclusion The enterprises should improve their sense of self-discipline,gradual establish a perfect quality management system, attach importance to the management of materiel and details,ensure the pertinence and effectiveness of training，and improve employee executive ability.

关 键 词：化妆品生产许可 缺陷项目 分析 建议 

分 类 号：R951[医药卫生—药学]