It is in the name of"non-compliance and major shortcomings" that the ANSM has just sent TECHNIC FRANCE (on which Kemesys laboratories depend) an injunction to bring its cosmetic activity into conformity. The shortcomings noted mainly concern non-compliance with GMP.
This injunction, dated June 10, 2015, follows an inspection by the ANSM carried out on the premises of the company TECHNIC FRANCE on January 21 and 22.
The facts complained of
The identification, status, release and re-evaluation of raw materials are not sufficiently controlled.
Controls and release of packaging items are not appropriate.
The sampling operations and weighing of raw materials are not carried out under satisfactory conditions with sufficient traceability.
The absence of control on finished products as well as the absence of satisfactory review of the batch file allowing finished products to be released by personnel in charge of quality.
The contracts to be reviewed with the principals in order to comply with the regulatory requirements concerning the production and keeping of the information file on cosmetic products as well as the eThese are
all points for which ANSM inspectors have identified non-conformities with ISO 22716, the standard for Good Manufacturing Practices.
The injunction
The company TECHNIC FRANCE is asked :
establish appropriate requirements for the identification, management of statutes, release and re-evaluation of raw materials,
- establish appropriate requirements- to ensure the removal and weighing of raw materials under defined and appropriate conditions- to define and carry out controls on finished products and to set up batch files incorporating the traceability of operations- updating responsibilities in contracts with principals and product labelling.
The whole is accompanied by a period of three months.
To go further
See Injunction n° 15COS098-INJ concerning the establishment of the company TECHNIC FRANCE, located 125 ZA le Verdalaï in Peynier (Bouches-du-Rhône), to download below.
