SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval of Corden Pharma Colorado API Manufacturing Location
January 20, 2014
SAFEBRIDGE® CONSULTANTS, INC. (SafeBridge) headquartered in Mountain View, California, has announced that Corden Pharma Colorado in Boulder, Colorado has met the criteria established under the SafeBridge program for "Potent Compound Safety Certification" and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) and compounds of unknown toxicity and potency. The SafeBridge Potent Compound Safety Certification of Corden Pharma Colorado applies only to specific laboratory and manufacturing areas involved in the manufacture of APIs and synthetic intermediates.
SafeBridge conducted a 60-element review of health and safety programs, procedures, exposure controls, and process containment of synthetic chemistry operations with occupationally potent active pharmaceutical ingredients at the company's site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that Corden Pharma Colorado meets current industry standards for the safe handling of potent APIs in the identified areas.
The SafeBridge Potent Compound Safety Certification program evaluates performance with established criteria in management, compound evaluation, exposure control, and communication elements of pharmaceutical production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology as well as industrial hygiene.
Since program inception in 1999 thirteen companies (and sixteen operating units) have achieved "Potent Compound Safety Certification". The Corden Pharma Colorado API facility joins nine other companies and twelve facilities actively involved in the SafeBridge Certification program.
Corden Pharma Colorado is part of Corden Pharma International, a contract manufacturing organization (“CMO”) that develops and manufactures oral, sterile, highly potent, and antibiotic pharmaceutical drug products and APIs and provides associated global supply chain and packaging services.
SAFEBRIDGE CONSULTANTS, INC. a subsidiary of Trinity Consultants, Inc., is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industries with offices in Mountain View, CA, New York, NY and Liverpool, UK. SafeBridge has provided the Potent Compound Safety Triangle® of services in industrial hygiene, occupational toxicology and industrial hygiene analytical chemistry to over 700 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent APIs and products.
For more information, contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229