At Aragen, we routinely evaluate drug substance and drug product stability under different ICH conditions. Our stability storage facility consists of walk-in and reach-out chambers, refrigerator and freezer storage and is fully secured with 24/7 electronic monitoring, alarm and power backup. Samples are analyzed using stability indicating analytical methods (SIAM) to enable data integrity, reliability and trend analysis. Our quality assurance systems support the monitoring, review and approval of stability studies prior to the issuance of reports.
