CordenPharma Announces Successful SafeBridge Recertification
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. 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,” said 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 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,” added Jason Bertola, Director, Global Highly Potent & Oncology Platform, CordenPharma International.
CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates – Injectables – Highly Potent & Oncology – Small Molecules – Antibiotics – CordenPharma experts translate complex ideas, processes, and projects at any stage of development into high-value products. For more information, visit www.cordenpharma.com. Inquiries: www.cordenpharma.com/contact-us/.
Total Page Views: 319