On January 6, 2022, the National Medical Products Administration promulgated the Manufacturing Quality Control Practices for Cosmetics (the “Practices”), which will go into effect on July 1, 2022. The Practices are highlighted below:
I. General provisions
The Practices constitute the basic requirements for quality control in cosmetics manufacturing. The registrants, recordants, and outsourced production enterprises (collectively, the “Enterprises”) for the cosmetics at issue are required to comply with the Practices, be honest and self-disciplined, and establish a quality control system in accordance with the Practices to attain control and traceability over the full process of cosmetics production, including purchase, production, inspection, storage, sales, recall, etc., of cosmetic materials, to ensure the continuous and stable production of cosmetics that meet the quality and safety requirements.
II. Institutions and personnel
The Enterprises should establish organizations and institutions that are commensurate with the varieties, quantities, and production licenses of the cosmetic products produced, clarify the duties and authorities of the quality control management department, the production department and others, and possess the technicians and inspectors that are commensurate with the varieties, quantities, production licenses, etc., of the cosmetics products produced. The Enterprises are required to set up an independent quality management department responsible for quality control and should be involved in all activities related to quality management.
The Enterprises should set up a cosmetics quality accountability system, stipulate the legal representatives (or the main responsible persons), the persons responsible for quality and safety, the responsible person of the quality management department, the responsible person for the production department, and other positions related to the quality and safety of cosmetic products. The people assuming these positions shall perform their responsibilities for the quality and safety of cosmetics at each level according to the requirements for their positions.
III. Quality assurance and control
The Enterprises are required to establish and improve documentation relating to the cosmetics production quality management system, establish and implement a document management system, record activities related to the Practices, establish and implement a traceability management system, a self-verification system for the quality management mechanism, an inspection management system, and a sample retention management system. The Enterprises should also set up laboratories that are commensurate with the varieties and quantities of as well as the production permits for the cosmetics produced, and establish and implement a management system for those laboratories.
IV. Plant facilities and equipment management
The Enterprises shall ensure that their production sites, facilities, and equipment are commensurate with the varieties and quantities as well as the production permits for the cosmetics produced. The Enterprises shall set up their production workshops in accordance with the production process and environmental control requirements, and separate the clean zones, quasi-clean zones, and general production zones. The Enterprises shall set up and implement a production equipment management system. For air purification and water production, storage, and delivery, the Enterprises shall ensure that the water consumption and the production workshop environment meet the requirements.
V. Materials and product management
The Enterprises shall establish and implement a supplier selection system, a review system, a delivery inspection and recordation system, and a shipment release management system for their materials. The quality and quantity of the water used for production shall satisfy the production requirements, and the water quality shall at least meet the hygiene standard and requirements of drinking water. The products shall comply with relevant laws and regulations, mandatory national standards, technical specifications and cosmetics registration, and the technical requirements contained in the recordation materials.
VI. Production process management
The Enterprises shall establish and implement a production management system that is commensurate with the varieties and quantities as well as the production permits for the cosmetics produced. A production work procedure and operational rules for production posts shall be established in accordance with the technical requirements set forth in the cosmetics registration and the recordation materials to ensure that production is done in accordance with those technical requirements.
VII. Outsourced production management
The registrants and recordants of cosmetics for outsourced production the (“Outsourcing Party”) shall establish a quality management system that is commensurate with the Practices and supervise the production by the outsourced enterprises. The Outsourcing Party shall set up an organizational structure that is commensurate with the registered or recorded cosmetics products and the needs of the outsourced production, clarify the responsible departments and their responsibilities with respect to registration or recordation management, production quality management, sales management and other key elements, and provide them with appropriate management personnel.
VIII. Sales management
The registrants, recordants, and outsourced production enterprises are required to set up and implement a sales recording system, a storage and transportation management system, a product quality complaint management system, a cosmetics adverse effect monitoring and evaluation system, a product recall management system, etc., and maintain relevant records.