SafeBridge Consultants, Inc. Announces “Potent Compound Safety Certification” Approval for AMRI High Potency API Facilities in Rensselaer, New York
January 20, 2010
SAFEBRIDGE® CONSULTANTS, INC. (“SafeBridge”), headquartered in Mountain View, California, has announced that AMRI's high potency research laboratories and
GMP-manufacturing facilities in Rensselaer, New York have met the criteria established under the SafeBridge program for “Potent Compound Safety Certification” and have been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients (“APIs”). The SafeBridge Potent Compound Safety Certification applies to specific AMRI laboratories and manufacturing areas designed for the research, development and manufacture of potent compounds.
SafeBridge conducted a 60-element review of AMRI programs, procedures and facilities used for the containment and control of potent APIs. Based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that AMRI 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, ten organizations have achieved “Potent Compound Safety Certification.” The AMRI Rensselaer facility joins seven 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 500 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