Potent Compound Manufacturing Safety, Health and Environmental Certification Program
SafeBridge has recently developed a potent compound certification program that provides an objective and scientifically supportable assessment of a company's ability to safely handle and manufacture potent compounds to industry standards. In order to be certified by SafeBridge, a company must meet minimum criteria in the management, evaluation, containment and control and communication elements of potent compound safety. Well-defined criteria and the program scoring regimen are shared with the client in advance. Elements of the certification program include an on-site assessment of both physical plant and equipment items (such as air pressure relationships, containment, and process technology) as well as program items such as process safety, training, medical surveillance, industrial hygiene, toxicology and environmental control.
The outcome is a written report and Letter of Certification. The report includes findings, comments and recommendations. Provided that the client meets the minimum criteria in each major assessment area, a Letter of Certification will be issued from SafeBridge and signed by board certified professionals. If the client excels in each major assessment area a certification as an industry leader will be issued. If the client does not meet the minimum criteria in each major area of assessment, then recommendations will be provided on how best to accomplish the minimum criteria.
The Certification Program can be used for internal assessment of programs as well as a marketing tool to attract new business for third party manufacturing.
Assuring Highly Potent Active Ingredients Safety: the SafeBridge Certification Program - by John Farris and Allan Ader is featured in the May 2004 edition of Chemistry Today