August 03, 2009
SAFEBRIDGE CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that DSM PHARMACEUTICALS, INC. (“DSM”), in Greenville, North Carolina, USA 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 potent drug products. The SafeBridge® Potent Compound Safety Certification applies to the site’s potent sterile fill/finish production area, specifically the Line 4 operation in Building 16, including the high containment fill/finish facility, and the associated quality control laboratories (Building 8).
SafeBridge conducted a 60-element review of programs, procedures, containment and control of the active pharmaceutical ingredients at the company’s site. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that DSM meets current industry standards for the safe handling of potent APIs and potent drug products in the identified areas.
The SafeBridge® Potent Compound Safety Certification program verifies performance with established criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.
Since program inception in 1999 eight organizations have achieved “Potent Compound Safety Certification”. The DSM North Carolina facility joins five other facilities actively involved in the the SafeBridge® Potent Compound Safety Certified program to date.
SAFEBRIDGE CONSULTANTS, INC. is the premier occupational health and safety consulting firm to the pharmaceutical, biotechnology and fine chemical industry 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 400 business units worldwide and is a leader in recognizing, evaluating and controlling exposures to potent active pharmaceutical ingredients and products.
For more information, contact:
John P. Farris, CIH
President and Chief Executive Officer
650-961-4820 x 229