Instrument Qualifications Q&A

Why qualify instruments?

The goal for the qualification is generally to document "evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data." -USP <1058>

Is instrument qualification necessary for the instruments in my laboratory?

  • GMP (pharmaceutical, med device): Yes, industry standard is for routine, documented qualification of instrumentation used for GMP testing.
  • Non-GMP labs (environmental, petrochemical): Generally no; system suitability tests or quality control checks are industry standard for these regulatory environments
  • GLP compliant labs (food, EPA regulated or animal health): Variable, depending on the internal requirement of each laboratory’s Quality Assurance Department

Please note: The final decision is always the responsibility of the equipment owner after cautious review of their lab’s regulatory requirements and equipment performance standards.

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