FDA Issues Final Guidance on Quality Agreements


Monitoring and Reporting Working Group

FDA has issued final guidance for industry entitled ‘‘Contract Manufacturing Arrangements for Drugs: Quality Agreements.’’

This guidance describes FDA’s current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements.

In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.

This guidance was effective on November 23, 2016

Click here to read the official FDA publication.