Introduction to Qualification

Hitherto, the scientific community has used the terms “validation” and “qualification” on an interchangeable basis thus creating a degree of ambiguity as to their use.

For this reason, USP have suggested that:

a) the term “qualification” be applied to instrumentation and
b) the term “validation” to processes and software

Hence the term “Analytical Instrument Qualification (AIQ)” is used for ensuring that an instrument is suitable for its intended application, and the term “Analytical Method Validation” is used for ensuring that the analytical and software procedures employed are suitable for their intended application.

The USP Chapter <1058> Analytical Instrument Qualification describes in detail a four phase approach to qualification based on design (DQ), installation (IQ), operational (OQ) and performance (PQ) qualification.

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