MTS HELPDESK:
What results should be reported on the Certificate of Analysis for an inconclusive OOS phase 2 investigation where the retest results are acceptable?
Category: OOS/OOT
Why not Retest in Phase 1 OOS Investigation?
MTS HELPDESK:
Why does the guidance from MHRA regarding investigation of out of specification (OOS) results not allow retesting in phase 1?
5 Golden Rules for Effective (and Inspection Ready) OOS Investigations
The investigation of out of specification (OOS) results is a regulatory requirement in a GMP laboratory and these investigations are intensively scrutinised by health authority inspectors. The purpose of this article is to provide 5 ‘Golden Rules’ which will make sure that investigations are both effective and inspection ready. Rather than use the term OOS […]