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 posted recently to the GHTF website. Comments are due March 25.

Another consideration for conducting audits is the criticality of the item or process being supplied, the guideline says.
The GMP Letter