化妆品生产许可“二证合一”后现场检查发现缺陷问题分析

Analysis of defects in on-site inspection after the"two licenses in one"for cosmetics production license

为监管部门开展化妆品生产许可现场检查及生产企业实施《化妆品生产质量管理规范》提供技术参考。通过对福建省化妆品生产企业在“二证合一”后首个换证周期(2016-2021年)160次现场检查中发现的缺陷问题进行统计、分析,找出存在的突出及共性问题。化妆品生产企业应增强质量管理意识,加强质量体系建设,提高风险意识,强化源头物料管理,提高全周期风险控制能力。

Technical references were provided for the inspection of cosmetics production license by regulatory authority and the implementation of Good Manufacturing Practice for Cosmetics.By summarizing and analyzing the defective items found in on-site inspection for cosmetics production enterprises in Fujian province after the“two licenses in one”from 2016 to 2021,the problems in quality management of cosmetic production were disclosed.The enterprises should improve their sense of quality management,gradually establish a perfect quality management system,attach importance to the management of materials and details,and improve the capability of full-cycle risk control.