Multiple-Site Audits Focus of GHTF Draft Guidelines

Devicemakers with a quality management system (QMS) that encompasses multiple manufacturing sites may see more efficient audits under new draft guidelines proposed by the Global Harmonization Task Force (GHTF).

The guidelines call for regulators to develop an audit program that eliminates the redundancy of multiple audits of centralized functions in a QMS comprising several manufacturing sites. The guidelines were proposed by Study Group 4 in July and recently posted to the GHTF website.

To create an audit program appropriate for all facilities under a single QMS, regulators should request information from the manufacturer on the QMS and the sites operating under it, the complexity and scale of the activities covered by a common QMS, and the person in charge of the QMS and the lead site.
The GMP Letter