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Introduction to Analytical Instrument Qualification – Part 1

Dec 7, 2020

Article

This article is Part 1 of a series.

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Part 2

When talking about the subject of Analytical Instrument Qualification (AIQ), my first thought is of regulated industries, such as pharmaceuticals and food. 

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You may be wondering—Why do we need to qualify analytical instruments in this environment? Why does my Titrando or my OMNIS system need such a service?

Consumer safety here is of paramount importance. Medicines that may represent a health hazard for patients or do not provide the intended therapeutic effect are undesirable and costly, therefore steps must be taken to safeguard the manufacturing process and prevent fatal implications. By qualifying the used analytical instruments, we can ensure that active ingredients and finished pharmaceutical products are manufactured in a safe environment.

In addition, procedures that prove instrument accuracy and repeatability are a must. Metrohm qualification procedures provide this documentation—fully traceable evidence which is also required for inspections and audits by regulatory authorities.