Trends In Quality Agreements & Communications: A CMO Perspective

By: Milton Boyer, Senior Vice President of Drug Product Manufacturing, AMRI

Outsourcing of all phases of pharmaceutical biological development, and the manufacturing activities surrounding those, are on the rise. As drug pipelines shift toward more complex and specialized capability, quality agreements and the communication associated with the planning of these complex operations are needed to avoid non-compliance and the costly ramifications associated with non compliance.

Simultaneously, there has been a dramatic increase in the number of official actions as measured by warning letters. These warning letters have showed that there is a more acute focus by the U.S. Food and Drug Administration (FDA) on the drug sponsor-CMO relationship. The agency has published a guidance formally defining roles and expectations of both drug sponsors and CMOs.