Deciphering VVQ: How Validation, Verification and Qualification Affect Total Organic Carbon Analyzers


With cleaning validation the fundamental question is ,"How clean is clean?" With Total Organic Carbon (TOC) instruments and methods, the question is whether to perform validation, verification, or qualification. Part of the question is not necessarily which mode to use, but, "Does the method or instrument 'suit' its purpose?" Given the current confusion regarding the use of TOC for compendial and analytical method purposes, this paper demonstrates what mode (validation, verification, or qualification) of choice should be used for TOC instrumentation or the methodology.