2020年婴幼儿和儿童化妆品生产企业专项检查发现缺陷情况分析

Analysis of defect findings in special inspection for infants and children’s cosmetics manufacturers in 2020

统计2020年国家药品监督管理局食品药品审核查验中心配合国家药品监督管理局开展的婴幼儿和儿童化妆品(以下简称“儿童化妆品”)生产企业专项检查情况,并分析儿童化妆品生产企业在生产合法合规性、物料管理情况、生产车间环境情况、产品生产控制情况、清洁消毒执行情况、生产检验记录情况、标签标识情况及上市后义务执行情况等8个方面的管理现状和存在的主要问题,并提出针对性建议,以引导和督促儿童化妆品生产企业提升质量管理能力和风险管控水平,并为药品监管部门提供参考。

A statistical analysis of the defect findings in the special inspection which was carried out by the Center for Food and Drug Inspection of NMPA in 2020 for infants and children’s cosmetics manufacturers was made.The current situation and the main problems in eight aspects were analyzed,including legal compliance on production,material management,workshop environment,production process control,cleaning and disinfection implementation,production inspection records,label identification,and post-marketing compulsory execution.Relevant suggestions were put forward,aiming at guiding infants and children’s cosmetics manufacturers to improve their quality control ability and risk control level,as well as providing reference for medical products administrations.