11.20.18
CordenPharma Colorado has successfully completed the Potent Compound Recertification Audit by SafeBridge Consultants. Certification has been maintained since first awarded in 2013.
The onsite assessment included the evaluation of physical plant features, programs, exposure controls, procedures and practices applied towards the manufacturing of highly potent active pharmaceutical ingredients (APIs), consisting of a review of over 60 elements.
By meeting the criteria established under the SafeBridge program, 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 endeavor that goes far beyond the installation of good containment equipment,” said Robin Livingston, manager, environmental, health and safety, CordenPharma Colorado. “The strength of our containment program is demonstrated by our approach from all directions, including engineering controls, a containment culture, process development, occupational health pre-planning, and an ongoing containment execution cycle.”
Jason Bertola, director, global highly potent and oncology platform, CordenPharma International, said, “CordenPharma Colorado has a long and successful history in manufacturing highly potent APIs, with robust processes in place to handle compounds well below 50ng/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.”
The onsite assessment included the evaluation of physical plant features, programs, exposure controls, procedures and practices applied towards the manufacturing of highly potent active pharmaceutical ingredients (APIs), consisting of a review of over 60 elements.
By meeting the criteria established under the SafeBridge program, 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 endeavor that goes far beyond the installation of good containment equipment,” said Robin Livingston, manager, environmental, health and safety, CordenPharma Colorado. “The strength of our containment program is demonstrated by our approach from all directions, including engineering controls, a containment culture, process development, occupational health pre-planning, and an ongoing containment execution cycle.”
Jason Bertola, director, global highly potent and oncology platform, CordenPharma International, said, “CordenPharma Colorado has a long and successful history in manufacturing highly potent APIs, with robust processes in place to handle compounds well below 50ng/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.”
