Update on SafeBridge potent compound safety certification programme
The programme provides drug innovators with an independent assessment of a manufacturing company’s ability to safely produce potent APIs and drug products
SafeBridge Consultants has updated the status of its programme to assist pharmaceutical and biotechnology companies to identify contract manufacturing organisations that are qualified in the safe handling of potent active pharmaceutical ingredients (APIs) and drug products.
The SafeBridge potent compound safety certification programme provides drug innovators with an independent assessment of the manufacturing company’s capabilities to safely produce potent APIs and drug products. The programme also provides pharmaceutical manufacturers with a metric to evaluate their own performance and to encourage continuous improvement.
The SafeBridge certification of the companies listed below applies to specific areas of their respective facilities involved in potent compound work, and the evaluation considers performance in more than 60 programme elements. The following manufacturing organisations continue to maintain their effective performance in the recognition, evaluation and control of potent compounds:
- SAFC Commercial (Madison and Verona, Wisconsin; St Louis, Missouri, USA)
- DSM Pharmaceuticals (Greenville, North Carolina, USA)
- Novasep (Le Mans, France)
- ScinoPharm (Tainan,Taiwan)
- Excella (Feucht, Germany)
- Albany Molecular Research (Rensselaer, New York, USA)
- Baxter Oncology (Halle and Bielefeld, Germany)
- Corden Pharma (Boulder, Colorado, USA)
- Pfanstiehl (Waukegan, Illinois, USA).
The certification programme and the related gap assessment programme (which utilises qualitative rather than quantitative scoring) have been used at numerous companies to assess their capabilities, including large pharmaceutical companies.
Certification is based on the successful implementation of the ‘systematic approach’ to potent compound safety, including ‘hardware’ (facility features, process equipment and engineering controls) and ‘software’ (programs, procedures and practices).
The on-site assessment includes evaluation of the physical plant features and equipment items (containment, process technology and ventilation systems) as well as assessing programme items such as occupational toxicology, industrial hygiene, safety, training and medical surveillance.
A company is considered certified after an on-site assessment by two experienced and board-certified SafeBridge health professionals and achieving the minimum scoring requirements in the following four major areas: programme management; hazard evaluation; containment and controls; and communication.