Qualification of analytical UV/VIS absorption spectrophotometers is a requirement in FDA-regulated laboratories. When in regulatory compliance, the spectrophotometer displays a calibration sticker to show that the spectrophotometer is “qualified” and ready to use by laboratory technicians and scientists. However, despite the required regulatory compliance, is it sufficient so that laboratory managers will have the necessary confidence to make informed and reliable decisions about the measurement results from the spectrophotometer?
This is not a trivial question. Because most calibration and metrology technicians are not analytical chemists and have not received formal training in analytical spectrophotometric metrology, the scientific metrological rigor of the scope and procedures of any given qualification can span the full scale – ranging from low rigor (higher laboratory risk) to high rigor (lower laboratory risk).
Unfortunately, at the present time, there is no official science-based procedural guidance that will facilitate uniform and consistent qualifications of spectrophotometers within the same laboratory or across different laboratories. As world-wide leaders in analytical spectrophotometric metrology, we can now be part of the solution by being available to provide certain metrology consulting services directly to FDA-regulated laboratories. Our consulting services, which are intended to assist in the evaluation and assessment of the scientific metrological defensibility of laboratory UV/VIS spectrophotometric qualification programs, have evolved with two (2) different scopes of program review:
- Comprehensive Review: Entire UV/VIS spectrophotometer qualification program
- Partial Review: Scientific critiquing of the Certificate or Report of Calibration issued for the “calibrated” filters intended for use in the qualification procedures <CERTIFICATE REVIEW>