Issue Date: November 23, 2016
Issued by: Center for Veterinary Medicine
Topic(s): Compliance, Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Final
Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry
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.
Download the Guidance Document
