Life Sciences
Potent Compound Safety Certification
A groundbreaking tool for drug innovators and contract manufacturing organizations.
Trinity Consultants’ SafeBridge group offers the SafeBridge® Potent Compound Safety Certification to contract development and manufacturing organizations (CDMOs) to assess their capabilities to safely handle potent active pharmaceutical ingredients (APIs). Our systematic approach provides an effective framework to protect worker health.
The SafeBridge® Potent Compound Safety Certification provides an objective and scientifically supportable assessment of a company's ability to safely handle and manufacture potent compounds to industry standards. To receive this certification, 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.
This comprehensive certification program includes an onsite assessment of both physical plant and equipment items (such as air pressure relationships, containment, and process technology), and program items such as process safety, training, medical surveillance, industrial hygiene, toxicology, and environmental controls.
Provided that the client meets the minimum criteria in each major assessment area, a letter of certification is issued, signed by board-certified professionals. Our clients use the SafeBridge® Potent Compound Safety Certification for internal assessment of programs and as a powerful marketing tool to attract new business for third party manufacturing.
Potent Compound Safety Triangle®
Trinity Consultants’ SafeBridge is known throughout the industry for the Potent Compound Safety Triangle® of services: Toxicology, Industrial Hygiene and Industrial Hygiene Analytical Chemistry. Our specific expertise is in the recognition, evaluation, and control of potential worker exposure and product safety issues associated with the handling of potent and highly potent drug substances and drug products.
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Featured Projects
Trinity's SafeBridge Group Identifies Chloracne Source in Research Lab
SafeBridge investigated an outbreak of chloracne in a discovery lab at a top 5 pharma company, determined the novel compound responsible for the outbreak and recommended a safe course of remediation.