Validation Center™

The EMEA GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections.  These inspections are usually requested during the initial review of a Marketing Authorisation Application, but could arise post-authorisation (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).

This document recommends using the PIC/S publication Guidance on Good Practices for Computerised Systems in "GxP" Envionments when performing inspections.  The PIC/S document is also available on the Validation Center web site.