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Tuesday, December 21, 2021Congresses

ANSM: inspections and news from the Agency

ANSM : les inspections et actualités de l'Agence

As every year, the control authorities take stock of their actions at the Perfumes & Cosmetics Congress. During the 19th edition, which took place in Chartres on December 1st and 2nd, 2021, Thomas Lecardez, Head of the INSMAR unit, and Manuela Boutillier, Cosmetics Inspector, have sacrificed to the tradition. On the agenda of their presentation were GMP inspections and certificates, declarations of establishments and the latest publications of the Agency.

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The 2020-2021 inspections

14 inspections were carried out during these two years, and three of them targeted manufacturers: figures that illustrate, in the words of Manuela Boutillier, “a significant decrease in ANSM’s resources.”
These inspections were mainly focused on compliance with the requirements of the ISO 22716 standard on good manufacturing practices, which remains one of the responsibilities of the manufacturer-Responsible Person, even if the products are subcontracted.

The main deviations

The safety report
We still see products being put on the market without a safety report. This is particularly the case when there is a lack of coordination between Regulatory Affairs and the departments responsible for marketing (usually marketing).
This is an opportunity for the Agency to recall that it is essential to coordinate, within companies, the regulatory requirements and the approval of the safety report BEFORE the products are placed on the market.

The release of raw materials
The ANSM focuses particularly on raw materials because it believes that they represent a greater risk than packaging items. But the issue of release is also valid for them.
The inspectors noted that some raw materials are released only on the basis of the supplier’s certificate of analysis. …

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