In response to frequently encountered issues by cosmetic manufacturing enterprises, Beijing Cosmetics Review and Inspection Center has provided detailed answers based on relevant regulations, including the Good Manufacturing Practices for Cosmetics, the Provisions on the Supervision and Administration of Enterprises’ Fulfillment of Responsibilities for the Quality and Safety of Cosmetics, and the Measures for the Administration of Cosmetic Inspection. CIRS Group has compiled the information and translated them into English for your reference.
Question 1: Can the retained samples used by cosmetic manufacturers for quality testing and stability testing be considered as the same batch’s retained samples for product release?
Answer: Article 18 of the Good Manufacturing Practices for Cosmetics clearly stipulates the packaging requirements for retained samples of released products. Specifically, for products released as finished products, the retained samples must maintain the original sales packaging; for products released as semi-finished products, the retained samples must be sealed. If the samples used by the enterprise for physicochemical testing, microbiological testing, and stability testing do not meet the above packaging requirements for retained samples of released products, they cannot be regarded as the retained samples for product release of the same batch.
Question 2: What are the requirements for retained samples of key raw materials by cosmetic manufacturers?
Answer: Article 30 of the Good Manufacturing Practices for Cosmetics stipulates that enterprises shall retain samples of key raw materials and keep corresponding retention records. The retained raw materials must be properly labeled, with the label including at least the Chinese name or code of the raw material, the name of the manufacturer, the specification of the raw material, storage conditions, and the expiration date, to ensure traceability. The quantity of the retained sample shall be sufficient to meet the requirements for quality testing of the raw material.
Question 3: Should the production consistency audit of a cosmetic manufacturer be conducted by the production department?
Answer: Article 17 of the Provisions on the Supervision and Administration of Enterprises’ Fulfillment of Responsibilities for the Quality and Safety of Cosmetics stipulates that enterprises shall establish a production consistency audit system for cosmetics. The person responsible for quality and safety shall, prior to the first production, review and manage the product formula, manufacturing process, product labeling, and other relevant aspects of the cosmetic product, and shall prepare a record of the production consistency audit. Retrospective audits shall be conducted regularly to ensure that the products manufactured comply with the technical requirements specified in the cosmetic registration or notification documents. The audit records shall include the name of the audited product, the registration certificate number for special cosmetics or the notification number for general cosmetics, the audit content, and other relevant information.
If the person responsible for quality and safety discovers any discrepancies between the product formula, manufacturing process, product labeling, etc., and the technical requirements specified in the registration or notification documents, or any other non-compliance with applicable laws and regulations, immediate risk control and other necessary measures shall be taken.
Question 4: If a cosmetic manufacturer adopts inspection as a quality control measure, how should the inspection items, methods, and frequency be determined?
Answer: Article 16 of the Good Manufacturing Practices for Cosmetics stipulates that enterprises shall establish and implement an inspection management system, and formulate quality control requirements for raw materials, inner packaging materials, semi-finished products, and finished products. Where inspection is adopted as a quality control measure, the inspection items, methods, and frequency shall be consistent with the technical requirements specified in the cosmetic registration or notification documents.
Question 5: What are the requirements for a corrective action report submitted by a cosmetic manufacturer as the inspected entity?
Answer: Article 17 of the Measures for the Administration of Cosmetic Inspection stipulates that the inspected entity shall, within the prescribed time limit, carry out corrective actions for the deficiencies and issues identified during the inspection, and submit a corrective action report as required. The corrective action report shall include the major issues identified, investigation and analysis of the problems, risk assessment, risk control measures, and the outcomes or effectiveness of the corrective actions taken.
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Further Information
https://yjj.beijing.gov.cn/yjj/xxcx/kpxc/hzp36/543509902/index.html
