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. Comments, which are only being accepted on QMS issues for device software, are due Friday.
The GMP Letter