China China issues standards for quality management in cosmetics manufacturing

China issues standards for quality management in cosmetics manufacturing

China’s National Medical Products Administration on Jan. 7 issued standards for quality management in cosmetics manufacturing.

These standards have been developed in accordance with the Regulations on Cosmetics Oversight, the Measures on the Manufacturing and Business Management of Cosmetics and other relevant regulations, and set out basic requirements for quality management in cosmetics manufacturing. Registrants, notifiers and contract manufacturers of cosmetic products must follow the standards once they come into effect on July 1. Here is an overview.

Chapters and Appendices

Chapter 1 General Provisions

Chapter 2 Organization and Personnel

Chapter 3 Quality Assurance and Control

Chapter 4 Management of Manufacturing Facilities and Equipment

Chapter 5 Management of Ingredients and Products

Chapter 6 Management of Manufacturing Processes

Chapter 7 Management of Contract Manufacturing

Chapter 8 Management of Product Sale

Chapter 9 Supplementary Provisions

Appendix 1 Requirements on Electronic Records of Cosmetics Manufacturing

Appendix 2 Requirements on Cosmetics Factory Environments

Organization and Personnel

Registrants, notifiers and contract manufacturers of cosmetic products must establish a division that manages items, quantities, production licenses, etc. of those products; clarify the responsibilities and authority of the quality management division, production division and other relevant divisions; and designate technicians and inspectors.

Cosmetics companies must establish a quality and safety responsibility system and clarify the responsibilities of the company’s legal representative, the person in charge of quality and safety, the persons in charge of the quality management division and the production division, and people in other positions related to quality and safety of cosmetic products. Chapter 2 of the standards defines these responsibilities in detail.

Quality Assurance and Control

Cosmetics companies are required to keep a record of all production activities relevant to the standards and implement a record management system.

Management of Contract Manufacturing

Registrants and notifiers of cosmetic products who entrust cosmetics manufacturing to another manufacturer must establish a quality management system and supervise the production by the contract manufacturer in accordance with the standards.

Other requirements are also imposed on entrusters, including designating a person in charge of safety, developing criteria for choosing contract manufacturers and establishing systems for employee health management and product shipping management.

Management of Product Sale

Registrants, notifiers and contract manufacturers of cosmetic products must implement a product sale record system and ensure that shipment documents, sale records and sold products are consistent with one another.

Each product sale record must include at least the product name; special cosmetics registry number or generic cosmetics notification number; expiration date; net amount; quantity; release date; price; and the name, address and contact information of the purchaser.

 

The full text of the standards (in simplified Chinese) is available at
https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220107101645162.html