GHTF: Additional Controls Advised With Single-Source Suppliers

Devicemakers should add supplemental controls to their own quality systems when single-source suppliers are unwilling or unable to demonstrate that they meet contractor selection criteria, according to a final Global Harmonization Task Force (GHTF) guidance on supplier controls. Although the guidance does not impose additional requirements on devicemakers, it illustrates that purchasing controls are linked to other components of the FDA’s quality systems, Kim Trautman, the FDA’s representative on the GHTF working group that prepared the guidance, said.
The GMP Letter