Equipment qualification for demonstrating the fitness for purpose of analytical instrumentation†

Abstract

Equipment qualification is the way to ensure that analytical equipment is fit for purpose. Qualification consists of four basic elements. Design qualification or DQ (Specification of what exactly the analytical scientist requires the equipment to do). Installation qualification or IQ (Does the instrument work to the manufacturer’s specification?). Operational qualification or OQ (Does the instrument work the way the analytical scientist wants it to?) and performance qualification or PQ (Does it continue to operate within the parameters monitored?). The background and approach discussed in this paper has been developed primarily within the pharmaceutical industry.

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