“Qualification of Analytical UV/VIS Spectrophotometers”

2018 Theme “Compliance with Science”

Stranaska Analytical Metrology Education Program
Jerry D. Messman, PhD – Course Instructor
Dates and Venues TBA

Qualification of analytical UV/VIS absorption spectrophotometers is a vital laboratory measurement assurance task and a key requirement particularly in the FDA-regulated life science industry. Many laboratories simply strive to be compliant with the minimum standard of practice reflected by USP and other international pharmacopoeial organizations. However, some laboratories aspire to a higher science-based standard of spectrophotometric measurement quality assurance that exceeds the minimum USP standard of practice.

This tutorial will include a critical comparison of the common practices for routine qualification from the pharmacopoeial perspective and advanced qualification from an analytical spectrophotometric metrology perspective. The contrasting UV/VIS qualification practices will be evaluated relevant to the following:

  • the scope of qualification or performance evaluation in accordance with the primary validation parameters for the method(s) run on the spectrophotometer
  •  the measurement scope of the reference materials used in the qualification process
  • the relative degrees of the calibrated states of the reference materials (including the scientific validity and defensibility of the declarations or assertions of the metrological traceability of their calibration results) derived from the routine and/or advanced calibration methodologies used by corporate metrology and commercial spectrophotometric calibration suppliers

This tutorial is intended for UV/VIS instrument service engineers and technicians, and measurement science professionals in analytical spectrophotometric calibration, metrology and laboratory quality control. The attendees will learn how to select the appropriate qualification practice that will be appropriate for implementation in their own laboratories.