China’s Cosmetics GMP (Good Manufacturing Practices) regulations and their corresponding GMP Inspection Points were recently utilized for an unannounced inspection of GP Club Co. Ltd., Seoul, Republic of Korea, a cosmetics manufacturer. The inspection was carried out by the National Medical Products Administration’s (NMPA) Center for Food and Drug Inspection (CFDI).
Cosmetics GMP Inspection Details:
Business Name: GP Club Co. Ltd
Address: 152, Wonhyo Road, Yongsan-gu, Seoul, Korea
Inspection Conducted By: NMPA’s Center for Food and Drug Inspection (CFDI)
Legal Basis for Inspection: Cosmetics Supervision and Administration Regulation (CSAR), Measures for the Supervision and Administration of Cosmetics Production and Operation, among others.
Key Findings:
– The inspection uncovered significant deficiencies at GP Club Co. Ltd, particularly in the areas of:
– Product Release Management: The company failed to implement a proper product release management system, which is essential for ensuring that only inspected and qualified products are released to the market.
– Supervision of Outsourced Production: There was a lack of an effective supervisory system to oversee the production activities of third-party manufacturers, which could lead to non-compliance with safety and quality standards.
Summary of Applicable China Cosmetics GMP Regulations:
To understand the gravity of the findings, it is crucial to reference the Cosmetics Good Manufacturing Practice (GMP) regulations that apply to such situations:
- Product Release Management (Chapter VI, Article 45):
– Enterprises must establish and implement a product release management system that ensures products are inspected, qualified, and all relevant production and quality records are reviewed and approved before they are released to the market.
- Supervision of Outsourced Production (Chapter VII, Articles 53, 54, and 55):
– The entrusting party (cosmetic manufacturer) must establish and implement comprehensive systems to manage and supervise all aspects of outsourced production, including:
– Quality Management: This includes registration, employee health management, training, self-inspection, and product release management.
– Supervision of Production Activities: The entrusting party is responsible for ensuring that the third-party manufacturer complies with statutory requirements and maintains adequate production conditions and capacity. If necessary, the entrusting party must replace the third-party manufacturer if they no longer meet these requirements.
– Appointment of a Quality and Safety Officer: The manufacturer must appoint a qualified individual to oversee the quality and safety of the products, manage the release process, and supervise outsourced production.
Recommendations for International Cosmetics Manufacturers
As a result of the above inspection results, international cosmetic manufacturers should consider the following best practices. This will help them to avoid similar issues and ensure compliance with Cosmetics GMP standards:
- Strengthen Product Release Management:
– Implement a thorough product release management system that mandates inspection and qualification of products before they are allowed on the market. Meticulously review and approve all relevant production and quality records.
- Enhance Supervision of Outsourced Production:
– Establish a robust supervisory system to monitor every aspect of the production activities of third-party manufacturers. Conduct regular audits and continuous monitoring to ensure compliance with legal standards and Cosmetics GMP regulations.
– Replace third-party manufacturers who fail to meet production or quality standards.
- Appoint a Qualified Quality and Safety Officer:
– Ensure that a knowledgeable and experienced individual is in charge of overseeing the quality and safety of products. This person should be responsible for decision-making regarding product quality, managing the release process, and supervising outsourced production activities.
- Regularly Review and Update Compliance Systems:
– Stay updated on changes in Cosmetics GMP regulations and ensure that all internal systems and third-party arrangements comply. Regular reviews and updates to the compliance systems are essential to maintain high standards of product quality and safety.
More information:
Read our article on China Cosmetics GMP Inspection Points
Read our article on China’s Cosmetics Good Manufacturing Practices
Read the original announcement by China’s NMPA
Discover our Cosmetics Filing & Registration Services
Reach out to us directly if you would like to book a Cosmetics GMP Pre-Audit of your factory or your sub-contractor
