AUDITOR PRIMER

Analytical UV/VIS absorption spectrophotometers fulfill critical laboratory needs in analytical testing, quality control and manufacturing support in the FDA-regulated healthcare industry. Spectrophotometer performance is of vital importance, and its documentation relevant to analytical instrument qualification is a specific area of focus in many laboratory types of regulatory audits and quality assurance inspections. However, very little official scientific metrological guidance is available that ensures a “qualified” spectrophotometer is indeed fit for its intended purpose in the laboratory.

Analytical spectrophotometric analysis traditionally resides in the realm of laboratory analytical chemistry. The logical extension of this is that the qualification of spectrophotometers should be underpinned by the guiding principles and concepts of analytical spectrophotometric metrology. Unfortunately, for many laboratories in the FDA-regulated healthcare industry, this may not always be the case, an unnecessary situation which puts those same laboratories at risk. To mitigate this real risk concern, we are drafting the Auditor Primer with relevant scientific guidelines that will allow a regulatory auditor or quality assurance specialist to quickly verify when an analytical UV/VIS absorption spectrophotometer is fully qualified and “fit for its intended purpose” or whether it could possibly be characterized as “under-qualified” despite its affixed calibration label.

Highlights of the Auditor Primer include, but are not limited to, the following sections:

  • Ramifications of the “Under-Qualified” Spectrophotometer – Can the laboratory trust calibration stickers?
    • False Negative Outcome – Procedural result action incorrectly rejects “passing” spectrophotometer
    • False Positive Outcome – Procedural result action incorrectly accepts “failing” spectrophotometer
    • Ownership and Responsibility for Wrong Qualification Assessments
  • Reasons for Under-Qualification of the Analytical UV/VIS Absorption Spectrophotometer – What are the factors that can cause it?
    • Use of qualification procedures that are not consistent with the scope of the analytical methods that are validated to be run on the spectrophotometer.
    • Measurement quantification of certain instrumental parameter tests are erroneous or misleading in trueness
    • Use of “flawed” optical filters that are not appropriate for the specific qualification parameter tests.
    •  Qualification testing conducted by calibration or metrology technicians or service engineers who are not degreed in analytical chemistry or who have not been fully trained in analytical UV/VIS absorption spectrophotometric metrology
  • Means of Identification of “Flawed” Optical Testing Filters – Can you trust the filter’s certification? What are the consequences?
    • Accreditation of a filter calibration supplier often undervalues the analytical science of its value assignment
    • Filter calibrations conducted by calibration or metrology technicians who are not degreed in analytical chemistry or who have not been fully trained in analytical UV/VIS absorption spectrophotometric metrology
    • Certificate or Report of Calibration reveals errors or misleading information, or it lacks transparency making it difficult to be able to independently reproduce certification measurements
    • Traceability claims and uncertainty intervals can not be metrologically substantiated, even for accredited suppliers
    • Use of filters that have expired or have had non-investigated out-of-tolerance (OOT) observations
  • Areas of Focus in Regulatory Audits or Quality Assurance Inspections – How do you examine the calibration sticker?
    • Documentation of credentials of personnel responsible for issuing the calibration sticker
    • Documentation of scope of the qualification and its relevance to the scope of the validated analytical methods to be run on the spectrophotometer
    • Documentation of science-based integrity of optical filters used in the qualification
  • Remedial Actions – How can you move beyond simple regulatory compliance to achieve documented science-based spectrophotometer qualification?
    • Comprehensive or partial review of your current UV/VIS spectrophotometer qualification program <METROLOGICAL SERVICES>
    • Documented science-based training of calibration and metrology technicians, supervisors and managers in analytical UV/VIS absorption spectrophotmetric metrology <SAMEC PROFESSIONAL>