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化妆品质量安全负责人有关问题探讨

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2021年1月1日起施行的《化妆品监督管理条例》首次确立了注册人备案人制度、质量安全负责人制度、功效宣称管理制度、风险监测和评价制度等一系列新制度.其中,质量安全负责人制度是压实企业主体责任的有效举措之一.《化妆品生产经营监督管理办法》《化妆品生产质量管理规范》《企业落实化妆品质量安全主体责任监督管理规定》等对质量安全负责人的岗位及职责作出了细化规定,明确其是落实质量安全责任制的"关键岗位"和"关键人员",对保障产品全生命周期质量安全意义重大.但笔者在实际工作接触中发现,很多化妆品企业尚未完全理解法规对质量安全负责人的要求,对其重视程度仍不够.本文从法规切入,详细阐述质量安全负责人的法定职责、履职条件、兼职及授权委托情形等,分析目前质量安全负责人在履职中存在的问题,给出解决建议,供行业参考.
Discussion on the Related Problems of the Person Responsible for the Quality and Safety of Cosmetics
The Regulations on the Supervision and Administration of Cosmetics,implemented on January 1,2021,established a series of new systems,including the registrant filing person system,the quality and safety responsible person system,the efficacy claim management system,and the risk monitoring and evaluation system.Among them,the quality and safety responsible person system is an effective measure to consolidate the main responsibility of enterprises.Regulations such as the Measures for the Supervision and Management of Cosmetics Production and Operation,Norms for the Quality Management of Cosmetics Production,and Regulations on the Supervision and Management of the Responsibility of the Main Body for the Implementation of Cosmetics Quality Safety by Enterprises provide detailed provisions on the roles and responsibilities of the quality and safety responsible persons,clarifying their significance as"key positions"and"key personnel"in implementing the quality and safety responsibility system throughout the product life cycle.However,in practical work,it has been observed that many cosmetics companies have not fully understood the regulatory requirements for the quality and safety responsible person,and their level of attention remains insufficient.This paper,starting from legal perspectives,elaborates on the statutory responsibilities,performance conditions,and authorization and delegation situations of the quality and safety responsible person,and analyzes the issues existing in the performance of the quality and safety responsible person,offering solutions for industry consideration.

cosmeticsquality and safety responsible personregulatory policiesperformance conditions

庞雪、董江萍、何淼

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沈阳药科大学工商管理学院

中国健康传媒集团

中国食品药品国际交流中心

国家药品监督管理局

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化妆品 质量安全负责人 法规政策 履职条件

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(2)
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