Beijing Municipal Medical Products Administration issued some faqs related to the quality and safety management mechanisms of general cosmetic filing on January 3, 2024.
What quality and safety management mechanism should the cosmetic registrant, filer, and entrusted manufacturer establish?
Enterprises shall establish a dynamic management mechanism based on cosmetic quality and safety risk prevention and control, combined with the actual enterprise situation, establish and implement work systems and mechanisms such as cosmetic registration and filing materials review, production consistency review, product batch-by-batch release, cause-triggered self-inspection, and quality and management self-inspection.
How do cosmetic registrants, filers, and entrusted manufacturers establish and implement a system for reviewing cosmetic registration and filing materials?
Cosmetic registrants, filers, and entrusted manufacturers shall establish a system for reviewing cosmetic registration and filing materials, specifying the requirements for the review time, content, procedures, responsibilities, records, and problem resolution of cosmetic registration and filing materials.
Before applying for product registration or filing (including initial application for registration or filing, registration and filing change, or registration renewal), the person in charge of quality and safety shall review the legality, authenticity, scientificity, and completeness of registration or filing materials such as product name, product formula, product implementation standards, product label, product inspection report, product safety assessment, and efficacy claim evaluation materials; If problems are found, immediate rectification should be organized, and product registration or filing applications should not be submitted until the rectification is completed.
Before submitting the annual report of general cosmetics, the person in charge of quality and safety shall organize an audit of the authenticity and accuracy of the content of the annual report; If problems are found, immediate rectification should be organized.
How do cosmetic registrants, filers, and entrusted manufacturers establish and implement a production consistency review system?
Enterprises shall establish a cosmetic production consistency review system, specifying the requirements for the review time, content, procedures, responsibilities, records, and problem resolution of cosmetic production consistency.
The person in charge of quality and safety shall review and manage the formula, production process, product labels, and other contents of the cosmetics produced before the first production, form a record of cosmetic production consistency, and regularly conduct retrospective reviews of relevant content to ensure that the products produced comply with the technical requirements stated in the cosmetic registration and filing materials. The record should include the name of the reviewed product, the registration certificate number of special cosmetics or the filing number of general cosmetics, the review content, etc. If the person in charge of quality and safety discovers that the formula, production process, product labels, and other contents of the produced cosmetics products are inconsistent with the technical requirements stated in the registration and filing materials, or do not comply with legal and regulatory requirements, measures such as risk control shall be immediately taken.
How do cosmetic registrants, filers, and entrusted manufacturers establish and implement a batch-by-batch release system for products?
Enterprises shall establish a batch-by-batch release system for products, clarifying the requirements for product release review content, release standards, release procedures, release responsibilities, release records, and disposal measures for products that are not released.
The person in charge of quality and safety shall organize the batch-by-batch review of products to ensure that each batch of released products is inspected and approved, the relevant production and quality activity records are reviewed and approved by the responsible person, and a product release record shall be formed. The record should include the release time of the product, the name, batch number, quantity of the released product, and the content of the release inspection. If the person in charge of quality and safety discovers that the product has quality and safety risks, they will stop the release, immediately organize risk control measures, and report to the legal representative promptly.
How do cosmetic registrants, filers, and entrusted manufacturers establish and implement a cause-triggered self-inspection system and a system for self-inspection of quality management?
Cosmetic registrants, filers, and entrusted manufacturers shall establish a quality management system self-inspection system, including annual self-inspection of the implementation of cosmetics production quality management standards and management requirements for a cause-triggered self-inspection system. The self-inspection system shall include self-inspection time, initiation situation, basis, responsibilities of relevant departments and personnel, procedures, result evaluation, and procedural requirements evaluation, rectification, shutdown, report of problems discovered during self-inspection.
The person in charge of quality and safety shall organize an annual self-inspection of the implementation of the cosmetics production quality management standards. After the self-inspection is completed, a report on the cosmetics production quality management system shall be formed. The report should include the problems discovered, product quality and safety evaluation, rectification measures, etc., approved by the quality and safety responsible person, report to the legal representative, and feedback to the relevant departments of the enterprise's quality and safety. The person in charge of quality and safety shall organize a follow-up evaluation of the rectification situation. Enterprise continuous suspension of production for more than 1 year, before re-production, the person in charge of quality and safety shall organize a comprehensive self-inspection to confirm whether the enterprise complies with the requirements of the cosmetics production quality management standards.
If the product sampling inspection results do not comply with regulations, the product may cause a significant social impact of cosmetic adverse reactions, or cause serious cosmetic adverse reactions involving product quality and safety, the person in charge of quality and safety shall immediately organize the adoption of risk control measures, initiate cause-triggered self-inspection system, and organize to formulate self-inspection plans, carry out self-inspection work, identify the reasons for the existence of quality and safety risks in the product, and eliminate risk hazards, and form a self-inspection report on initiating cause-triggered self-inspection system. The report shall include the reasons for the self-inspection, problems discovered, product quality and safety evaluation, rectification measures, etc., approved by the quality and safety responsible person, report to the legal representative, and feedback to the relevant departments of the enterprise's quality and safety. After the self-inspection and rectification are completed, the person in charge of quality and safety shall organize an evaluation of the cosmetics production quality management system. After the evaluation, it is deemed that the risk factors affecting the quality and safety of cosmetics are eliminated before the corresponding control measures can be lifted.
If the person in charge of quality and safety discovers that the above-mentioned situations involving product quality and safety belong to significant safety risks, they shall immediately report to the legal representative and propose rejection suggestions such as stopping the production and operation of related cosmetics. The legal representative shall organize research and take disposal measures.
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