Cosmetics GMP in China came into force on July 1, 2022. The China cosmetics GMP consists of 9 chapters and 67 articles and applies to cosmetics products, both finished and semi-finished. Semi-finished products are those which have completed all stages of production except for filling & finishing and labelling.
The key points of the cosmetics good manufacturing practices cover:
- Institutions & people
- Quality Assurance & Control
- Plant facilities and equipment management
- Materials and product management
- Production process management
- Entrusted production management
- Product sales management.
The China cosmetics GMP details the fundamental requirement for the quality management of cosmetics production. The cosmetics GMP requirements apply to:
- cosmetics registrants and filers who manufacture their own cosmetic product
- cosmetics registrants and filers who entrust the manufacture to third parties or companies within their corporate group
- entrusted cosmetic manufacturers
All of the above will be referred to hereafter as cosmetics enterprises.
Cosmetics registrants/filers and entrusted manufacturers shall:
- establish a production quality management system in accordance with the requirements of this GMP
- realize the control and traceability of the whole process of cosmetic material procurement, production, inspection, storage, sales and recall, etc.,
- and ensure the continuous and stable production of cosmetics that meet the quality and safety requirements.
Institutions & People
Cosmetics enterprises shall establish a cosmetics quality and safety responsibility system which shall clarify:
- the responsibilities of the legal representative (or main person in charge)
- the person in charge of quality and safety
- the person in charge of the quality assurance management
- the person in charge of the production department
- and any other positions related to the quality and safety of cosmetics.
The personnel for each post shall perform the corresponding cosmetics quality and safety responsibilities in accordance with the duties of that post.
Of particular importance is the person in charge of Quality & Safety who shall:
- have professional knowledge related to the quality and safety of cosmetics, chemistry, chemical industry, biology, medicine, pharmacy, food, public health or law, etc.,
- be familiar with relevant laws and regulations, mandatory national standards, technical specifications,
- and have more than 5 years of experience in cosmetics production or quality management
- and shall assist the legal representative to undertake the following cosmetic product quality safety management and product release duties:
- Establish and organize the implementation of the quality management system, and regularly report on the running of the quality management system to the legal representative
- Take decisions on product quality and safety issues and issue relevant documents
- Manage audits of product safety assessment reports, formulas, production processes, material suppliers, product labels, etc., as well as audits of cosmetics registration and filing materials (except for entrusted production enterprises)
- Manage material release and product release
- Monitor and manage cosmetic adverse reactions.
Quality Assurance & Control
Cosmetics enterprises shall establish and implement a quality management system self-inspection system:
- Enterprises shall conduct a self-inspection in line with the good manufacturing practices for cosmetics every year
- If there is a continuous suspension of production of more than 1 year, a self-inspection shall be carried out before re-production can commence to confirm whether China GMP requirements are still being met
- If the cosmetics sampling inspection results do not meet national standards are unqualified, self-inspection shall be carried out in a timely manner and rectification shall be carried out in accordance with the regulations.
Cosmetic manufacturers shall establish in-house laboratories that are consistent with the varieties, quantities and production license items of the cosmetics produced, and at least have the inspection capacity of microbial inspection items such as:
- the total number of colonies
- the total number of mold and yeast.
They must also ensure that the testing environment, inspectors, and inspection facilities, equipment, instruments and reagents, culture media, and standards meet the inspection needs.
Cosmetic enterprises should establish and implement a sample retention management system:
- Each batch of products leaving the factory should be kept in samples, and the number of samples should be at least 2 times the quantity needed for factory exit control inspections, and should meet the requirements of product quality inspection
- The retention period shall be not less than 6 months after the expiration of product use period
- If the product leaving the factory is a finished product, the sample should be kept in the original sales packaging
- If the product leaving the factory is a semi-finished product, the sample should be sealed and the stability of product quality should be ensured. Labelling information should meet requirements to ensure traceability.
Plant facilities and equipment management
- Cosmetics manufacturers should divide and designate production areas as clean, quasi-clean and general production areas on the production workshop in accordance with the requirements of the product process environment
- Production workshops and other places shall not store or produce materials, products or other items that adversely affect the quality and safety of cosmetics
- Manufacturers should establish and implement air purification systems.
Materials and product management
Cosmetic manufacturers shall establish and implement a record system for the inspection and recording of incoming materials:
- Establish and implement material acceptance procedures, clarify material acceptance standards and acceptance methods
- Enterprises should keep samples of key raw materials and keep sample records
- The water quality and quantity of the production water used by the enterprise shall meet the production requirements, and the water quality shall at least meet the requirements of the sanitary standards for drinking water
- Enterprises shall establish and implement a label management system and review and confirm product labels. The production process marked on the inner packaging material shall be completed in the production enterprise that completes the last production process in contact with the contents of cosmetics.
Entrusted production management
The registrant/filer of the entrusted cosmetics (hereinafter referred to as the “entrusting party”) shall establish a corresponding quality management system in accordance with the provisions of the China cosmetics GMP and supervise the production activities of entrusted manufacturer.
Where cosmetics are entrusted for production, the entrusting party shall be the registrant/filer of the cosmetics produced.
The entrusted manufacturer shall be a company holding a valid cosmetics production license and accept the entrustment within the scope of its production license.
The entrusting party shall:
- nominate a person in charge of quality and safety internally
- establish and implement a supervision system for the production activities of the entrusted manufacturer
- establish and implement a replacement system for the entrusted manufacturer
- establish and implement a product release management system
- establish and implement a sample retention management system
- establish and implement a record management system. Where relevant records for the implementation of the China cosmetics GMP are kept by the entrusted manufacturer, the entrusting party shall supervise its preservation of the relevant records.
Product sales management
- Cosmetics registrants, filers and entrusted manufacturers shall establish and implement a product sales record system, and ensure that the shipment documents and sales records of the products sold are consistent with the actual goods.
- Product sales records shall include at least the product name, special cosmetics registration certificate number or ordinary cosmetics filing number, use period, net content, quantity, sales date, price, as well as the buyer’s name, address and contact information.
- Cosmetics registrants/filers shall establish and implement a monitoring and evaluation system for adverse reactions to cosmetics. The entrusted manufacturer shall establish and implement a monitoring system for adverse reactions of cosmetics.
- Cosmetics registrants, filers, and entrusted manufacturer shall be equipped with departments and personnel appropriate to the varieties and quantities of cosmetics they produce, carry out adverse reaction monitoring work in accordance with regulations, and form monitoring records.
- Cosmetics registrants/filers shall establish and implement a product recall management system and carry out recall work in accordance with law. If it is found that product quality defects or other problems may endanger human health, the production should be stopped immediately and a product recall should be initiated. All relevant cosmetic operators and consumers should notified to stop sales or use of the product. Recalled products should be clearly marked and stored separately. Any remedial, harmless treatment, destruction or other measures shall be taken as appropriate. For cosmetics recalls and treatment due to product quality problems, the cosmetics registrant/filer shall promptly report to the drug supervision and management department of the province, autonomous region or municipality directly under the Central Government
- The entrusted manufacturer shall establish and implement the product cooperation recall system.
- Cosmetics registrants/filers and entrusted manufacturers engaged in the preparation of semi-finished products only shall organize production in accordance with the requirements of this GMP.
- The quality management of toothpaste production is carried out in accordance with this GMP.
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