The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
A recent study conducted by Eli Lilly's research laboratories
division suggests that quantitative ion mobility spectrometry
(qIMS) can offer drugmakers a rapid on-site means of verifying the
cleanliness of manufacturing equipment.