Quality Agreements With Contract Manufacturing Organizations (CMOs)

By James Jardine, GxP Lifeline Editor, MasterControl

The rapid pace of innovation and growing competition in the life sciences sector has prompted many companies to shift toward asset-light operational models, relying more heavily on partnerships with contract manufacturing organizations (CMOs). As this approach gains momentum, it is essential for both CMOs and the companies they serve to maintain strict adherence to the U.S. Food and Drug Administration’s (FDA) current good manufacturing practice (cGMP) regulations. Explore seven essential details to include in an effective CMO quality agreement.