Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 63)

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

1. How should the client establish a quality and safety responsibility system?

The system should be based on their organizational structure. This involves allocating, authorizing, and implementing responsibilities across various departments, specific positions, specific management personnel, and operators involved in the entire quality assurance system. Responsibilities are typically defined in writing through job responsibility documents or authorization letters for key roles such as the legal representative of the company (or the main person in charge), the person responsible for quality and safety, managers of registration activities, production quality management, product sales management, and other positions related to cosmetic quality and safety. All company personnel should perform their quality and safety responsibilities according to the requirements of their respective job responsibilities, ensuring that the related performance records are authentic and traceable.

2. What should a document management system generally include?

• Document Creation/Revision, Release, and Implementation Process: This should clearly define the process for drafting or revising, reviewing, approving, issuing, training, using, and the disposal of documents.
• Document Control Measures: It is important to establish controls for document management to ensure that the documents created are effectively implemented and controlled. For example, relevant personnel should be trained and familiar with the contents of the documents; at the site of use, only the latest and valid versions should be available to prevent the misuse of obsolete documents.
• Regular Evaluation of Documents: The created documents should be regularly evaluated and, if necessary, revised or abolished in a timely manner.
• Recycling of Obsolete Documents by the Quality Management Department: The quality management department should promptly collect documents that have become obsolete due to revisions, changes in version, or abolition. The enterprise should retain at least one copy of each controlled obsolete document to meet traceability requirements, while other obsolete documents should be destroyed and records of their destruction kept.

3. How should the production records of a contract manufacturing organization be preserved?

Production records should generally follow the principle of "who generates, who preserves." Therefore, records should be kept by the implementers of the related activities. In contract manufacturing, records related to product production, inspection, and release formed by the contract manufacturing organization should, in principle, be preserved at the contract manufacturer's site. The client may keep copies as needed. The client is responsible for supervising the authenticity, completeness, and security of the production records kept by the contract manufacturer. Records generated from the quality management and supervision of the contracted production by the client should be preserved by the client.

4. What are the requirements for product release?

Contract manufacturing operates under a "dual release" system. The client, based on the completion of the product release by the contract manufacturing organization, ensures that the product has passed inspection and that the related production and quality activity records have been reviewed and approved before the product can be released to the market. The specific review for release is generally conducted by the quality management department, and the release documents should be reviewed and signed by the head of the quality department and approved and signed by the quality and safety officer or their authorized personnel. The enterprise should generate records of product release, which should include the time of release, the name, batch number, quantity of the released product, details of the release inspection, and the conclusions of the review and approval.

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