SAFC, a division of Sigma-Aldrich in the US, has been certified competent and proficient in the safe handling of potent active pharmaceutical ingredients (APIs) at its plant in St Louis, Missouri by SafeBridge Consultants. The SafeBridge potent compound safety certification applies specifically to the site’s antibody drug conjugate (ADC) manufacturing and process development facilities and associated quality control laboratories in Building N3 within the St Louis manufacturing site.
California-based SafeBridge conducted a 60-element review of programmes, procedures, containment and control of the APIs at the site. Of four new companies seeking SafeBridge certification in 2009, SAFC St Louis is the first to be certified.
The SafeBridge 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. www.safebridge.com www.sigmaaldrich.com/safc-pharma/en-us/home.html