This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.
Any time a contractor or CMO is used, including arrangements between different divisions of the same company, regardless of the location of the parties involved, there should be a quality agreement in place.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.