It is because of “non-compliances and significant deficiencies” that the ANSM has just sent to NEOCOS company a compliance injunction concerning its Pierrelaye facility. The cause: several deviations relating to compliance with the requirements of ISO 22716 on Good Manufacturing Practices.
This injunction, dated December 10, 2019, follows an inspection of the ANSM carried out at the premises of this company on June 4 and 5, 2019.
The alleged facts
• The independence of the quality which is not assured and its level of staffing which is not adequate to ensure the control of quality assurance activities.
• The undefined and non-isolated picking area.
• The dressing of personnel according to the different zones and flows not managed.
• Lack of control of the cleaning agents of the equipment.
• The identification of raw materials and packaging items not managed.
• Incompleteness of raw material controls and their re-evaluation.
• Lack of control of microbiological control protocols by the personnel in charge of this activity.
• The absence of audits of subcontractors.
• Incompleteness of the batch file.
• The absence of a complete documentation system.
The injunction
The ANSM enjoins the company NEOCOS to:
• Redefine the organisation of the quality department within the establishment in order to ensure its independence, in particular as regards the control and release of products, and associate adequate resources to guarantee the follow-up of non-conformities, within 3 months
• Set up the separation and …
