For nearly 20 years, SAFC in partnership with [now] Novazymes has provided Long R3 IGF-I as a key raw material to biopharmaceutical manufacturers for the production of their marketed recombinant protein drugs via cell culture. Everyone is aware that requirments for quality standards, supply chain management and transparency, and risk management strategies have increased steadily over that period -- and will continue to do so to protect patient safety and enhance regulatory desired consistency in manufacturing.
SAFC and Novazyme have issued a short document outlining and updating our current risk management strategy with Long R3 IGF-I. It addresses risk management of inventory/safety stock, offsite storage, second-stie manufacture, quality standards and external audit program, manufacturing capacity, product safety and risk assessment and management. See below for the plan.
Posted by Bruce Lehr December 20th 2010.