Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 60)

We have collected the latest FAQs on ordinary cosmetics filing from the Guangzhou Administration for Market Regulation and translated them into English for your reference.

Q1. In the context of cosmetics contract manufacturing, what obligations should the contracting party undertake?

The contracting party should be the registrant or the filer of the cosmetics produced. They should establish a corresponding quality management system and organizational structure, and be responsible for the quality, safety, and efficacy claims of the cosmetics throughout their entire lifecycle. They are required to fulfill obligations related to registration and filing management, supervision of production activities, as well as post-market adverse reaction monitoring, evaluation and reporting, product risk control and recall, and reassessment of the safety of products and ingredients.

Q2. What quality management-related systems should the contracting party establish?

The contracting party should establish and implement quality management-related systems including, but not limited to, the following:

• management of cosmetics registration and filing;
• health management of employees;
• training of employees;
• self-inspection of the quality management system;
• product release management;
• product sample retention;
• product sales records;
• product storage and transportation management;
• product return records;
• product quality complaint management;
• product recall management; and
• systems for monitoring and evaluating adverse reactions to cosmetics.

Additionally, when providing materials to the contracted manufacturing company, the contracting party should also establish and implement systems related to material supplier selection, material review, records of material procurement inspection and acceptance, and material release management, in accordance with the requirements of the Good Manufacturing Practices for Cosmetics.

Q3. How should the contracting party implement a sample retention system?

The contracting party should retain samples on its own and must not delegate this task to the manufacturing company. The contracting party should retain samples at its residence or main place of business, or at other business premises located within the same prefecture-level city or municipality directly under the central government, typically considered as within the same administrative region. If the sample retention location is not at the residence or main business location, the contracting party must report the address and other relevant information of the sample retention location to the local drug regulatory authority within 20 working days from the date of the first sample retention, in accordance with regulations.

Q4. How should the contracting party supervise the production activities of the contracted manufacturer?

The contracting party should establish a system to supervise and manage the production activities of the contracted manufacturing company, specifying the content, methods, frequency, and procedures for addressing any issues identified during supervision. Based on its own circumstances, the contracting party should take effective supervision measures. In practice, these could include deploying quality management personnel at the contracted manufacturer, conducting unannounced on-site inspections, or performing regular sample testing. These measures are intended to ensure that the contracted manufacturing company produces in accordance with legal and regulatory requirements, the technical specifications stated in the registration and filing documents, and the quality requirements outlined in the contracting agreement, while also maintaining records of the supervision.

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