GHTF Spells Out Triggers for Audits of Suppliers

Manufacturers that don’t inspect supplier products and services and don’t get their suppliers certified by a third party may be subject to more supplier audits, according to a new guideline proposed by the Global Harmonization Task Force (GHTF). Regulators also may consider postmarket complaints and insufficient supplier history when determining whether to audit a manufacturer’s suppliers, according to the guideline, issued by Study Group 4 Nov. 13 and posted recently to the GHTF website. Comments are due March 25.
The GMP Letter