Tuesday, August 18, 2015ANSM

Télécharger l'injonction de l'ANSM à ICP France en format .PDF

It is in the name of"non-compliance and significant breaches" that the ANSM has just sent the company ICP France (specializing in the development, manufacturing and packaging of cosmetic products) an injunction to bring its business into compliance. This is due to several deviations from the ISO 22716 GMP standard.

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This injunction, dated 30 July 2015, follows an inspection by the ANSM carried out on the premises of ICP France from 2 to 4 March last.

The facts complained of

(a) the absence of separation, protection and cleaning of all areas where good manufacturing practices are to be applied in accordance with Chapter 4 of the harmonised standarde NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products;
b) the absence of a cleaning and disinfection programme for all production equipment in accordance with Chapter 5.5 of standard 22716;
c) non-conformities relating to the identification, management of the articles of association, the release of raw materials, packaging items and finished products and the revaluation and inappropriate storage of raw materials in accordance with chapters 6.4, 6.5, 6.6, 6.7 and of standard 22716;
d) the lack of control of the status of finished products sent to principals in accordance with chapters 8.1, 8.2 and 8.4 of standard 22716;
e) the lack of control of water used in production in accordance with chapter 6.8 of Standard 22716;
f) traceability of insufficient production operations and batch records that are not established to ensure compliance with Chapters 7.1, 7.2, …

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