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Quality Management System according to ISO 22716

Regulation (EC) no. 1223/2009 imposes the use of the UNI EN ISO 22716 (the so called Cosmetic GMP) for the manufacturing of cosmetics under the Good Manufacturing Practice.

The grounding requirement of Regulation (EC) no. 1223/2009 consists in making the company that places the cosmetic product on the market fully responsible, including for all those technical aspects previously being a prerogative of the sole manufacturer.

The MA holder of the product, even when only performing trading activities, is obliged to verify that the manufacturer follows the Good Manufacturing Practice provided for the cosmetic sector, and to include the manufacturing process and a declaration of conformity to the cosmetic GMP in the technical dossier of cosmetic products (PIF – Product Information File).

Di Renzo Regulatory Affairs has qualified experts for the cosmetic sector and for quality requirements.  Therefore, we can assist companies in the document assessment and in the performance of audits to verify the compliance with the cosmetic GMP.