During the 5th RQC (Rencontres de la Qualité Cosmétiques), organised by IFIS and FEBEA, Victoria Caldy, Business Development & Marketing Director of Cisema (a consulting company specialised in regulatory affairs and quality in China), gave a complete overview of the new requirements that the new Chinese cosmetic regulation, the CSAR, has introduced in terms of GMPs (Good Manufacturing Practices), quality and safety of products. The second part of his presentation was on the qualification requirements for quality and safety managers, technical standards, and the monitoring of adverse reactions.
Qualification requirements for quality and safety officers
Quality and safety officers must be appointed to meet the requirements set by the CSAR, but also the specific requirements of GMPs. This applies to the registrant as well as to the mandated manufacturer and the local responsible agent, who must therefore also have a quality and safety manager in China.
It should be noted that in China, the safety dimension is added to that of quality, in the sense that it is necessary to ensure that the product, beyond its quality, is not likely to endanger the health of the consumer.
According to Article 32 of the CSAR, the safety officer must have:
• Professional knowledge in cosmetic safety and quality management
• More than five years of experience in cosmetic production or in the field of safety and quality management
However, the NMPA considers that such a person may have equivalent experience in the field of medicinal products, medical devices or special food products, provided that he/she can demonstrate specific knowledge in cosmetic safety, management and quality.
Staff health checks
And it does not stop there, as certain requirements also apply to all personnel in contact with cosmetic products.
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