Multiple-Site Audits Focus of GHTF Draft Guidelines
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
The GMP Letter