“An inspection is like a wedding: an important phase of preparation before, a day or two for the event, and long-lasting consequences, later.” This joke, by Anne Laissus-Leclerc, director of Regulatory Affairs at LVMH-Research, set the tone of her presentation: inspections from a practical point of view.
So here is her “to do list” in 3 chapters: before, during and after the inspection.
1. Before
Who?
Generally, apart from "denouncements or major concerns" (with products quality or safety), inspectors send a “prior notice," by fax, followed by mail or e-mail (Afssaps), or by e-mail (DGCCRF), usually 15 days in advance. Thus, a first advice: make sure that mail, in whatever form, is thoroughly dealt with in the company, especially during holidays, or after an employee has left the company.
What?
The aim of an inspection varies: it could be a site (raw materials, GMP …), Product Information Files (PIF), claims, categories of products, etc. It may also cover several items.
•
1st example:
a letter from the Afssaps, to LVMH headquarters, planning a visit 15 days later, by 2 inspectors, in the Saint-Jean-de-Braye site, asking to prepare the list of Raw Materials and Finished Products.
A priori, the conclusion is that:
1/ the inspection will not deal with the control of the cosmetic file, as the site that will be inspected is the production site (and not the address written on the product label),
2/ nevertheless, there is no indication about which documents and/or products will be …
