September 18, 2009
SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that Novasep – Le Mans (Seripharm) (”Novasep”) in Le Mans, France 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 only to specific laboratory, kilo lab and manufacturing locations utilized for the manufacture and handling of potent compounds.
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 Novasep meets current industry standards for the safe handling of potent APIs 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 Novasep Le Mans facility joins six other facilities actively involved in 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