What to do to be prepared for a GMP inspection? Obviously, by implementing in the company the relevant procedures to guarantee the Good Manufacturing Practices. Further, on a more psychological level, by knowing who will come, to do what, on D-Day. The 6th Regulatory Meeting, organized by the French Cosmed, on June 21, had this same topic on its agenda.
Prior to Martine Jouannic (JM Conseil), who explained the main points to check and improve to comply with the ISO 22716 standard and the requirements of the European Regulation on cosmetics, which was fully implemented on 11 July 2013, Stéphanie Garrel, the Responsible of the Regulatory Oversight in the Cosmed association, has reminded the audience of the frame of the GMP inspections that are likely to occur.
In France, as per the Article L5431-1 of the Code of Public Health, two kinds of people are allowed to look for and record GMP offenses. The legal frame differs, depending on the authority. In any case, they may be announced, though, in fact, most of them are unannounced.
Afssaps, Inspecting Pharmacists and Physicians
To be more precise, they are:
• The inspecting pharmacists of Public Health, and the inspectors of the regional health agencies who are pharmacists,
• The Afssaps (now the French National Agency of Medicines, ANSM) inspectors,
• The Inspecting physicians of Public Health and the inspectors of the regional health agencies who are physicians.
What can they do?
•
Look for and record offenses
• Seize the products with a judge's warrant
• Require to be given all the …
