The subjects of this Regulation are cosmetic registrants, filers, and entrusted production manufacturers (hereinafter collectively referred to as "enterprises").
Production quality management system: cosmetics registrants, filers and entrusted manufacturers should achieve the whole-process control and traceability of cosmetics materials procurement, production, inspection, storage, sales and recall.
Cosmetics quality and safety responsibility: Enterprises should clarify the legal representative, the person in charge of quality and safety, the person in charge of the quality management department, the person in charge of the production department and other related positions, each position should be in accordance with the requirements of job responsibilities and fulfill the responsibilities of cosmetics quality and safety at the respective levels.
Enterprises should have the person in charge of quality and safety, the person should have cosmetics, chemical, biological, medical, pharmacy, food, public health or law and other professional knowledge of cosmetics quality and safety, familiar with relevant laws and regulations, mandatory national standards, technical specifications, and has more than 5 years of cosmetic production or quality management experience.
- Quality assurance and control
Self-inspection system of quality management: Enterprises should conduct annual self-inspection of the implementation of quality management standards for cosmetics production, including time, basis, relevant departments, personnel responsibilities, procedures and results assessment. If there is a continuous shutdown of more than 1 year, before re-production it should be self-inspection to confirm whether it meets the requirements of this Regulation; if the sample test results fail, it should be carried out a timely self-inspection and rectification as required.
Enterprises should establish required laboratory compatible with the production of cosmetic varieties, quantities and production license projects, at least with microbiological testing capabilities, and to ensure that the testing environment, testing personnel and testing facilities, equipment, instruments, reagents, culture media and standards to meet the needs of the test.
Sample management: Each batch of products should be kept for sampling, the number of samples kept should be at least two times the demand for factory inspection, and should meet the requirements of product quality inspection.
Enterprises should follow the environmental requirements of the product process, the production plant is divided into clean areas, quasi-clean areas and general production areas. Production plant and other places must not be stored and produced materials, products or other items that have an adverse effect on the quality and safety of cosmetics.
- Materials and product management
Material purchase inspection records, key raw materials preservation and sampling, and label management audit.
Water quality and quantity of production water should meet the production requirements, the water quality should at least meet the requirements of domestic drinking water hygiene standards.
- Production process management
Enterprises should clarify the production process parameters and key control points of the process, the main production process should be verified to ensure continuous and stable production of qualified products.
- Entrusted production management
Entrusted manufacturers should hold a valid cosmetic production license, and within the scope of its production license to accept the entrustment.
Entrusting party should establish and implement a product release management system, on the basis of the entrusted manufacturers to complete the factory release of the product to ensure that the product has passed the inspection and related production and quality activities records are reviewed and approved before listing the release.
- Sales management of products
Product sales records: Ensure that the shipping documents, sales records and products sold are consistent, including at least the product name, special cosmetic registration certificate number or ordinary cosmetic record number, expiration date, net content, quantity, date of sale, price, as well as the name, address and contact information of the purchaser.
Monitoring and evaluation of adverse reactions to cosmetics: Enterprises should be equipped with appropriate department and personnel with their cosmetic varieties and quantities, carry out monitoring of adverse reactions and form monitoring records.
Product recall management: The recall and treatment of cosmetics implemented due to product quality problems should be promptly reported to the regulatory authorities of drugs.
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Mr. Mike Chang (Partner)