It is in the name of"non-compliance and significant shortcomings" that the ANSM has just sent SECOS (cosmetics manufacturer) an injunction to bring its activity into conformity. This is due to several deviations from the ISO 22716 GMP standard.
This injunction, dated 27 July 2015, follows an inspection by the ANSM carried out on the premises of SECOS from 17 to 19 March last.
The facts complained of
a) the independence of the quality is not assured and the control and release activities are not carried out by personnel responsible for the quality in accordance with the harmonised standard NF EN ISO 22716 ;
(b) lack of separation, identification and/or appropriate protection and maintenance of all areas where good manufacturing practices are to apply; (
c) flows are not defined in accordance with harmonised standard 22716;
(
e) the control, release and reassessment of raw materials intended for the manufacture of cosmetic products(
f) production operations are insufficiently traceable, batch records are not reviewed and finished products are not released by quality personnel.
The injunction
(a) redefine the organisation of the establishment's activities to ensure the independence of the quality unit, in particular for inspection and release(
b) establish the identification, separation and protection of the areas and their cleaning within 3 months(
c) define the flows ensuring the protection of products and minimising the risks of mixing products, materials or packaging items,
within a period of three months(b) to …
