1. What are the requirements for the legal representative of the cosmetic registrant, the filer, and the entrusted production enterprise in the relevant regulations on cosmetics?
(1) According to the Good Manufacturing Practice for Cosmetics, the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities, the legal representative of the enterprise shall meet the following requirements:
The legal representative is fully responsible for the quality and safety of cosmetics, and shall be responsible for providing necessary resources, and reasonably formulate and organize the implementation of quality policies to ensure the achievement of quality objectives. (Article 6 of the Good Manufacturing Practice for Cosmetics)
(2) The legal representative shall ensure that the person in charge of quality and safety carries out the quality and safety management of cosmetics in accordance with the law, and urge the quality and safety-related departments of the enterprise to cooperate with the person in charge of quality and safety in their work. The legal representative should fully listen to the opinions and suggestions of the person in charge of quality and safety before making major decisions related to the quality and safety of cosmetics. (Article 11 of the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities)
(3) The legal representative in the case of entrusting other personnel of the enterprise to carry out the overall management of the enterprise, the legal representative can entrust the above-mentioned delegate to perform the overall management of cosmetics quality and safety on behalf of the legal representative. The legal representative shall sign a power of attorney with the delegate, clarifying the quality management responsibilities that the delegate shall fulfill with corresponding authority, and the performance of its duties on behalf of the legal representative can be traced. The legal representative shall supervise the performance of the delegate's duties. (Article 6 of the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities)
(4) The legal representative or its entrusted delegate who performs the overall management of cosmetics quality and safety, shall strengthen the study of cosmetic quality and safety management knowledge and relevant laws and regulations, and have the ability to make the right decisions on major issues of cosmetic quality and safety. (Article 7 of the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities)
2. What are the requirements for the person in charge of cosmetic quality and safety?
According to Article 7 of the Good Manufacturing Practice for Cosmetics, the person in charge of quality and safety shall possess professional knowledge of cosmetic quality and safety related to cosmetics, chemistry, chemical industry, biology, medical science, pharmacy, food, public health, or law, be familiar with relevant laws and regulations, mandatory national standards, technical specifications, and have more than 5 years of relevant professional experience.
The person in charge of cosmetic quality and safety, on the premise of possessing professional knowledge related to cosmetic quality and safety, its production or quality management experience in drugs, medical devices, and special foods, can be considered to have production or management experience in cosmetics.
3. What are the requirements for the ability to perform the duties of the person in charge of quality and safety of the cosmetic registrant, the filer, and the entrusted production enterprises engaged in cosmetic production activities?
According to Article 10 of the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities, the person in charge of quality and safety in enterprises shall possess the following abilities to perform their duties:
(1) Ability to apply professional knowledge. Possess professional knowledge related to cosmetic quality and safety that meets the requirements of fulfilling job responsibilities, and be able to apply it in quality and safety management work;
(2) Ability to apply legal knowledge. Be familiar with laws and regulations related to cosmetics, and able to ensure that the quality and safety management of the enterprise complies with laws and regulations;
(3) Ability to organize and coordinate. Have the leadership to organize the implementation of the enterprise's cosmetic quality and safety responsibility system, and be able to effectively organize and coordinate the work of relevant departments involved in quality and safety;
(4) Ability to assess risk. Be familiar with cosmetic quality and safety risk management, and able to accurately identify and judge potential product quality risks that may arise in enterprise production and operation activities, and propose countermeasures;
(5) Other necessary abilities for cosmetic quality and safety management.
4. The person in charge of quality and safety of the cosmetic registrant, the filer, and the entrusted production enterprise engaged in cosmetic production activities designate other personnel of the enterprise to assist in fulfilling its responsibilities, what are the requirements?
According to the Good Manufacturing Practice for Cosmetics, and the Provisions on the Supervision and Management of Cosmetics Enterprises Quality and Safety Responsibilities, the person in charge of quality and safety can designate others to assist in fulfilling the duties, and the following requirements shall be met.
(1) If the person in charge of quality and safety designates other personnel of the enterprise to assist in fulfilling the responsibilities, it should be agreed in writing by the legal representative. Its legal responsibility will not be transferred to the designated personnel;
(2) The designated personnel shall have corresponding qualifications and abilities to perform the duties. The time and specific matters of the designated personnel assisting in performing the duties shall be truthfully recorded to ensure that the assistance in performing the duties can be traced;
(3) The person in charge of quality and safety shall supervise the assistance in fulfilling the duties, and the enterprise shall establish a supervision system for the assistance of the person in charge of quality and safety in fulfilling the duties, clarify the supervision method and frequency of the person in charge of quality and safety in supervising the designate person, and form a record of performance supervision;
(4) The following two responsibilities shall not be assigned to others for assistance in fulfilling: establish and organize to implement the enterprise's quality management system, implement quality and safety management responsibilities, and regularly report the operation of the quality management system to the legal representative; Decision-making on product quality and safety issues and signature and release of relevant documents.
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