The latest regulations on cosmetics production quality management standards and the latest GMP verification of cosmetics are formulated by the National Medical Products Administration in accordance with regulations and rules such as the "Regulations on the Supervision and Administration of Cosmetics" and the "Measures for the Supervision and Administration of Cosmetics Production and Operation". They were released on January 7, 2022 and will come into effect on July 1, 2022.
This specification consists of 9 chapters and 67 articles, covering multiple key sections. In terms of organization and personnel, enterprises are required to establish organizational structures that are suitable for production scale and product categories, and clarify the responsibilities of each department. The person in charge of quality and safety should have relevant professional knowledge in cosmetics, chemistry, chemical engineering, etc., with more than 5 years of experience in cosmetics production or quality management, and be responsible for key responsibilities such as product quality and safety management and release. The head of the production department should also have relevant professional knowledge and experience to ensure production compliance.
At the level of quality management, enterprises should formulate quality policies and objectives, establish a sound quality management system document, including quality management systems, standards, production formulas, process specifications, and operating procedures. Effective control of documents should be implemented to ensure that valid versions are used, and a traceability management system should be established to ensure traceability of product production, quality control, and other activities.
In the quality control process, enterprises must establish a product inspection management system, formulate quality standards and inspection methods for materials and products, and conduct inspections or confirmations. It is necessary to have a laboratory that is suitable for the production scale and product category, including inspection facilities, equipment, and instruments, and has the ability to conduct product factory inspections on its own. The microbiology laboratory should be able to monitor the microbiological indicators of the production environment, process water, materials, and products.
In terms of factory facilities and equipment management, enterprises should have suitable production sites, facilities, and equipment. The layout of the production workshop should be reasonable to prevent cross contamination. If there are requirements for environmental parameters such as temperature, humidity, and air cleanliness, corresponding control equipment should be equipped. The selection and installation of equipment should meet production requirements and be easy to clean, disinfect or sterilize. Enterprises should establish equipment management systems to standardize equipment procurement, installation, use, maintenance, cleaning, etc.
Material and product management requires enterprises to select, evaluate, and approve material suppliers, establish a material release management system, and ensure material quality. Materials and products should be stored under specified conditions, classified and placed in batches, and clearly labeled.
In the production process management, enterprises should establish production process regulations and job operation regulations in accordance with the technical requirements stated in the cosmetics registration and filing materials, clarify production process parameters and key control points, and verify the main production processes. The production process should clearly label materials and semi-finished products throughout the entire process, fill in production records truthfully, completely, and accurately, check material balance after production, clean up the site in a timely manner, and clean and disinfect equipment, etc.
Enterprises that have obtained cosmetics production licenses before July 1, 2022, and need to upgrade or renovate their factory facilities, equipment, and other hardware conditions must complete the upgrade before July 1, 2023, in order to comply with the requirements of the "Cosmetics Production Quality Management Standards", further improve the overall level of cosmetics production quality management, and ensure product quality and safety