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Tag: OOS/OOT
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 […]