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Thursday, June 28, 2012Congresses

GMP: the points to address

©CosmeticOBS-L'Observatoire des Cosmétiques

From 2010 to 2011, the number of GMP inspections has almost doubled in France. The point, for the authorities, is to check how companies comply with the ISO 22716 standard, the sole true reference in this area, before the implementation of the Regulation on cosmetics, in which GMP is mandatory. The Regulatory Meetings organized by the French Cosmed association on June 21 are a way to draw our attention both on the controls and on the main causes for non-compliance, found during the inspections.

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GMP, it is urgent to be prepared, as CosmeticOBS-L’Observatoire des Cosmétiques said some time ago in its file dedicated to the requirements arising from the European Regulation nbr 1223/2009, which was implemented in its entirety on 11 July 2013. In its Article 8, it requires following Good Manufacturing Practices. It seems that too many companies are still in need of adaptation to be in full compliance with the new regulation.

During the Cosmed 6th Regulatory Meeting, a conference given both by Stéphanie Garrel, Responsible for Regulatory Oversight in Cosmed, and Martine Jouannic (JM Conseil), has fingered out an increased pressure by the authorities on this point, and the points to address to meet the requirements.

Stéphanie Garrel began by presenting the results of the GMP inspections performed by the French agency Afssaps (now, the National Agency for the Safety of Medicines, ANSM): 17 in 2010 (out of a total of 53 inspections), 30 in 2011 (out of 55 inspections). A clear signal that this area is a priority for the control authorities, even if they still work currently mainly on an “educational level.”
However, as of July 2013, the result of their evaluations may be a far different song … …

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