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.

For more information about Pace's Instrument Services, contact us at service@pacelabs.com or 612.656.1175.

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