SafeBridge Updates Potent API and Drug Manufacturer Status

SafeBridge Consultants has updated status of nine manufacturing organizations in the SafeBridge Potent Compound Safety Certification program, which is designed to assist pharmaceutical and biotechnology companies in identifying contract manufacturing organizations qualified in the safe handling of potent APIs and drug products.

The program offers drug innovators an independent assessment of the manufacturing company's capabilities for safe production of potent APIs and drug products. The program also provides pharmaceutical manufacturers with a metric to evaluate performance and to encourage continuous improvement.

SafeBridge Certification reports that the following organizations continue to maintain their effective performance in the recognition, evaluation, and control of potent compounds:

• SAFC Commercial, Madison, WI;

• SAFC Commercial, St. Louis, MO;

• DSM Pharmaceuticals, Greenville, NC;

• Novasep, Le Mans, France;

• ScinoPharm, Tainan, Taiwan;

• Excella, Feucht, Germany;

• Albany Molecular Research Inc., Rensselaer, NY;

• Baxter Oncology, Halle, Germany;

• Corden Pharma, Boulder, CO; and

• Pfanstiehl, Waukegan, IL.  

Certification is based on the successful implementation of a systematic approach to potent compound safety, including facility features, process equipment, and engineering controls; and programs, procedures, and practices. The on-site assessment includes evaluation of the physical plant features and equipment, as well as assessing occupational toxicology, industrial hygiene, safety, training, and medical surveillance programs, according to a SafeBridge statement.

A company is considered certified after an on-site assessment by two board-certified SafeBridge health professionals and achieving the minimum scoring requirements in program management, hazard evaluation, containment and controls and communication.

Source: SafeBridge Consultants