On Friday 13 November, Catalent’s softgel plant in Beinheim, France received a notification from l’Agence National de Sécurité du Médicament et des produits de santé (ANSM) requiring the suspension of manufacturing within the site. As the world’s leading provider of softgel capsules, the company takes all matters related to the quality and supply of its products extremely seriously and has been working diligently with all relevant authorities in order to resolve the situation as quickly as possible.
Catalent has been investigating the occurrence of out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients. The company’s preliminary investigation indicates that it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate action by one or more individuals. Catalent has subsequently notified the appropriate law enforcement authorities of the occurrence of the incidents by filing a written complaint. Catalent is also cooperating fully with the ANSM during its inspection and investigation.
The facility’s quality team has conducted complete risk assessments in accordance with Catalent’s quality management system, including the re-assessment and re-inspection of batches produced during the periods in which these incidents occurred. Additionally, the site leadership team has implemented, in accordance with the quality management system, significant additional security and access control measures to limit access to products, and they have been reinforcing all relevant policies and procedures with all operators in order to ensure utmost vigilance and compliance with Catalent’s established processes. The company is now working with the ANSM to determine what additional measures may be necessary to minimize any future occurrence. Catalent has assembled resources and experts from around its global quality and manufacturing organizations to provide full support in expediting the resolution of this issue.
The Beinheim site has developed and manufactured softgel capsules since 1965, produces over 2 billion doses every year, and 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 site supplies dozens of important medicines to patients around the world. In the last two years, the facility has been subject to seven local and international regulatory inspections with no critical observation, as well as two dozen customer audits conducted as a part of those clients’ Supplier Quality Assurance programs.
Catalent employs a robust global Quality Management System and aims to comply with all national and international regulatory and quality standards at all times, including the ANSM (France), the FDA (USA), ANVISA (Brazil), and the MHRA (UK). Catalent considers its quality standards to be among the most rigorous in the industry and its compliance track record to be excellent. Catalent conducts regular cGMP training for all staff, and employees are rigorously tested in order to demonstrate high competency levels for their roles.
