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Life-Sciences eQMS 21 items

Equipment Qualification (IQ/OQ/PQ) Checklist

Verifies that manufacturing equipment is installed, operates, and performs as intended through Installation, Operational, and Performance Qualification. Use during equipment commissioning and requalification.

21 CFR 211.63ICH Q7ASTM E2500

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Prerequisites and Documentation

  • Are user requirement specifications (URS) approved for the equipment? *
  • Is a design qualification or risk assessment completed to link requirements to critical aspects? *
  • Are the IQ/OQ/PQ protocols approved before execution? *
  • Is the equipment covered by a preventive maintenance and calibration program? *

Installation Qualification (IQ)

  • Is the equipment identity, model, and serial number verified against the purchase specification? *
  • Are utilities (power, air, water, gas) connected and verified against requirements? *
  • Are materials of construction of product-contact surfaces documented and compliant? *
  • Are instrument calibration certificates present and traceable at installation? *
  • Are manuals, spare parts lists, and SOPs available? *

Operational Qualification (OQ)

  • Are operating ranges and setpoints challenged and verified across the intended range? *
  • Are alarms, interlocks, and safety functions tested and confirmed? *
  • Are control system functions and access controls verified where applicable? *
  • Are worst-case operational conditions challenged? *

Performance Qualification (PQ)

  • Is the equipment challenged under actual or simulated production conditions with product or surrogate? *
  • Are performance results reproducible across the required number of runs? *
  • Do results meet the pre-defined acceptance criteria? *
  • Record the number of PQ runs completed.

Deviations and Release

  • Are all qualification deviations documented, investigated, and resolved? *
  • Is a qualification summary report approved before the equipment is released for GMP use? *
  • Is the equipment added to the requalification/periodic review schedule? *
  • Quality approval to release equipment for use. *

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