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Equipment Qualification (IQ/OQ/PQ) Checklist

Esta lista de verificación está en inglés.

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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