It is in the name of"non-conformities and important failures" that the ANSM has just sent to the Société Française de Fabrication de Cosmétiques (S.F.F.C.) an injunction to bring its Mourenx establishment into conformity. The cause: several discrepancies relating to compliance with the requirements of the ISO standard on Good Manufacturing Practices.
This injunction, dated 17 October 2017, follows an inspection by the ANSM carried out on the company's premises from 15 to 17 February 2017.
The facts complained of
- The absence of separation, identification and/or protection of the weighing area where good manufacturing practices must apply in accordance with Chapter 4 of the harmonised standard NF EN ISO 22716 of January 2008. - The lack of definition of adapted cleaning programmes for all production equipment in accordance with chapter 5.5 of the harmonised standard NF EN ISO 22716 of January 2008. - The absence of audits of subcontractors in charge of manufacturing and/or packaging in accordance with chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008.
The injunction
The ANSM enjoins the Société Française de Fabrication de Cosmétiques (S.F.F.C.) : 1. to set up a separation in order to ensure the protection of the weighing room within 6 months; 2. finalize the demonstration of the effectiveness of cleaning programs for all equipment within 3 months; 3. to undertake an audit of subcontractors to ensure that subcontracted operations are under control within 6 months.
To go further
- See the
Injunction n° 17COS014-INJ concerning the establishment of …
