Why Outsource Stability Programs?

Outsourcing Stability Programs: Strategies for Success

Authors: Stephen P. Mayock and Anita Koltay, Catalent

Stability studies, required at all phases of the drug development lifecycle, are essential for gaining regulatory approval. The increasing industry trend has been to outsource stability studies to contact research organizations (CROs). The authors, managers in quality control and stability services at Catalent, discuss how to make the decision to outsource, navigate the vendor selection process, manage the stability project start-up, and monitor the study and vendor metrics. A table lists critical factors for assessing a contract laboratory performing stability studies.