Using The QTA To Align Data -Integrity Expectations

By Kip Wolf, X-Vax Technology, @KipWolf

Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). While current FDA guidance “does not explicitly apply to the manufacture of investigational, developmental, or clinical trial materials, the FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements.” The principles described in the guidance and here in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities. This includes CMOs/CDMOs as well as those that supply third-party laboratory and analytical services, as “cGMPs apply to all contract facilities, including analytical testing laboratories.”