Overview
ABSTRACT
The quality of analysis results relies on the training and experience of analysts, and also on the validity of analytical methods and the reliability of equipment. This article covers the essential points in the qualification of analytical instruments: regulatory requirements, terminology, qualification phases and documentation, and gives examples of tests for a broad variety of analytical instruments.
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Read the articleAUTHORS
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Huguette FABRE : Professor Emeritus, Analytical Chemistry Laboratory, University of Montpellier, UFR Pharmacy, Montpellier, France
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Marie-Dominique BLANCHIN : Senior Lecturer, Analytical Chemistry Laboratory, University of Montpellier, UFR Pharmacy, Montpellier, France
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Catherine PERRIN : Professor, Analytical Chemistry Laboratory, Université Montpellier, UFR Pharmacie, Montpellier, France
INTRODUCTION
Equipment qualification, which demonstrates that the equipment is fit for purpose and is properly maintained and calibrated, is a prerequisite for the method validation stage, which consists of studying the method's performance in terms of certain criteria (specificity/selectivity, accuracy, precision, linearity, detection and quantification limits, application range, robustness). Subsequently, it is necessary to ensure that the system's performance is maintained during routine application of the method, using system compliance tests and/or quality control samples. In the pharmaceutical industry, compliance tests are generally reserved for chemical analyses and come under "Good Manufacturing Practice", while quality control samples are the rule in bioanalysis, which comes under "Good Laboratory Practice".
These various stages form a "quality triangle", the basis of which is equipment qualification and validation of the associated IT system (not covered here). At all stages, it is necessary to "demonstrate", i.e. to provide documented, tangible proof, by supplying records and data, and recording results in data sheets.
This article covers the essential data needed to set up equipment qualification in an analytical laboratory, which is the cornerstone of this triangle of quality.
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KEYWORDS
calibration | accuracy | freedom from bias | instruments | qualification test
Qualification of analytical instruments
Regulatory requirements
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