Update on SafeBridge Potent Compound Safety Certification Program
By Business Wire News
By Business Wire News
MOUNTAIN VIEW, Calif.
SafeBridge Consultants, Inc. (“SafeBridge®”) has issued an updated status of their ground-breaking program to assist pharmaceutical and biotechnology companies in identifying contract manufacturing organizations qualified in the safe handling of potent active pharmaceutical ingredients (“APIs”) and drug products. The SafeBridge Potent Compound Safety Certification program allows drug innovators to have 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 their own performance and to encourage continuous improvement.
The SafeBridge Certification of the companies listed below applies to specific areas of their respective facilities involved in potent compound work, and the evaluation considers performance in more than sixty (60) program elements. The following manufacturing organizations continue to maintain their effective performance in the recognition, evaluation and control of potent compounds:
- SAFC® Commercial in Madison, Wisconsin (multiple API sites in both Madison and Verona, Wisconsin)
- SAFC Commercial in St. Louis, Missouri
- DSM Pharmaceuticals in Greenville, North Carolina
- Novasep in Le Mans, France
- ScinoPharm in Tainan, Taiwan
- Excella in Feucht, Germany (both Oral Solid Dosage drug product and API facilities)
- Albany Molecular Research Inc. (AMRI) in Rensselaer, New York
- Baxter Oncology in Halle, Germany (multiple sites in both Halle and Bielefeld, Germany)
- Corden Pharma Colorado in Boulder, Colorado
- Pfanstiehl in Waukegan, Illinois
The Certification program and the related Gap Assessment program (which utilizes qualitative rather than quantitative scoring) have been used at numerous companies to assess their capabilities, including big pharmaceutical companies.
Certification is based on the successful implementation of the “systematic approach” to potent compound safety, including “hardware” (facility features, process equipment and engineering controls) and “software” (programs, procedures and practices). The on-site assessment includes evaluation of the physical plant features and equipment items (containment, process technology and ventilation systems) as well as assessing program items such as occupational toxicology, industrial hygiene, safety, training, medical surveillance. A company is considered Certified after an on-site assessment by two experienced and board-certified SafeBridge health professionals and achieving the minimum scoring requirements in the following four major areas:
1. Program Management
2. Hazard Evaluation
3. Containment and Controls