The congress in Chartres, France, is usually an opportunity for ANSM representatives (the French National Agency for Medicines and Health Products Safety) to provide the industry with an overview of the inspections and critical deviations found. The 12th edition of the event was no exception, with Thierry Thomas and Vanessa Picot coming to give a reminder on the regulatory inspections and the GMPs.
Thierry Thomas is the Inspection & Market Surveillance Unit Manager, and Vanessa Picot is a Cosmetic Products Inspector. Together, they first took stock of the regulatory inspections.
How are the inspections conducted?
Both ANSM agents started with a reminder of the methodology applied during an inspection, with several points being controlled:
• Strategy for placing cosmetic products on the market, from development to design: formalization of the strategy, approval of the raw materials, upstream safety assessment, stumbling blocks…
• Integration of the changes made to the regulations in 2013: responsible person, PIF, notification, ‘reinforced’ safety assessment, GMPs, distributors, nanomaterials, common criteria for claims…
• Review of regulatory files and verification of labelling related to the files reviewed
• Management of complaints and cosmetovigilance by the company: procedures, centralization, follow-up, tendency and/or recurrence
• Subcontracting management: agreement, description of technical responsibilities, audits…
• Product recall management: traceability, procedure, recall exercise performed…
Inspection campaigns
Some inspections are conducted as part of thematic campaigns (at least one per year). The ANSM agents took stock of the last two carried out.
2013: teeth-whitening products
On July 9, 2013, the ANSM published a ‘DPS’ ( Décision de Police Sanitaire , public health decision) to ban …
