Certification has been maintained since first awarded in 2013.
The onsite assessment included the evaluation of physical plant features, programmes, exposure controls, procedures and practices applied towards the manufacturing of highly potent active pharmaceutical ingredients (APIs), consisting of a review of more than 60 elements.
By meeting the criteria established under the SafeBridge programme, CordenPharma Colorado is deemed competent and proficient in the safe handling of potent APIs and compounds.
“Containment of highly potent compounds is a multi-faceted endeavour that goes far beyond the installation of good containment equipment. The strength of our containment programme is demonstrated by our approach from all directions, including engineering controls, a containment culture, process development, occupational health preplanning and an ongoing containment execution cycle,” comments Robin Livingston, Manager, Environmental and Health & Safety, CordenPharma Colorado.
“CordenPharma Colorado has a long and successful history in manufacturing highly potent APIs, with robust processes in place to handle compounds well below 50 ng/m3 OEL."
"SafeBridge’s recertification provides objective and scientifically supported assessment further validating our capabilities to support customers with any challenge they bring our way,” says Jason Bertola, Director, Global Highly Potent & Oncology Platform, CordenPharma International.
