Catalent forced to suspend production after possible employee product sabotage
pharmafile | November 17, 2015 | News story | Manufacturing and Production |
Catalent has been forced to halt production at one of its French softgel capsule factories after the US-based manufacturer identified what it has called a deliberate attempt to sabotage production.
The concerns arose after the discovery that the wrong capsules had apparently been intentionally mixed into several product batches. It is believed a plant employee is responsible.
The Beinheim facility in north-east France received a suspension notice from regulators at the l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) on Friday.
Catalent said in a statement that it was ‘highly unlikely’ that the out-of-place capsules discovered during quality control procedures could have been accidentally misplaced or due to the failure of a control process and surmised it likely that it was ‘deliberate malicious action’ by one or more individuals.
The out-of-place capsules were discovered prior to distribution to customers and removed, yet the company said it has no idea how long production would have to be on hold.
Beinheim has produced softgel capsules since 1965, manufactures more than 2 billion doses per year, and according to Catalent has an “excellent regulatory track record…thanks to robust quality controls and to the work carried out by its more than 300 qualified employees.”
The Beinheim site is one of eleven softgel manufacturing facilities in Catalent’s worldwide manufacturing network of 31 sites. The company describes itself as the world’s leading producer of softgel capsules: drugs in liquid form within a soft shell.
Catalent emphasised the fact that it conducts regular cGMP (current Good Manufacturing Practice) training for all staff, and that employees are rigorously tested in order to demonstrate high competency levels for their roles.
The company added it would work with clients to deal with any interruption in supplies and it is working with regulators to resolve the situation as quickly as possible and determine any necessary action to prevent any repeat of the incident in future.
Joel Levy
