DSM Pharmaceuticals gains SafeBridge certification
DSM Pharmaceuticals in Greenville, North Carolina, US has been certified competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) and drug products by SafeBridge Consultants.
DSM Pharmaceuticals in Greenville, North Carolina, US has been certified competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) and drug products by SafeBridge Consultants.
The SafeBridge potent compound safety certification applies to the site's potent sterile fill/finish production area, specifically the Line 4 operation in Building 16, including the high containment fill/finish facility, and the associated quality control laboratories (Building 8).
California-based SafeBridge conducted a 60-element review of programmes, procedures, containment and control of the APIs at DSM's site.
The certification programme verifies performance with established criteria in management, evaluation, containment, control and communication elements of potent compound production operations. It includes on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.
