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    IQ / OQ / PQ

    Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    IQ verifies that equipment is installed per specification; OQ verifies that it operates within defined limits; PQ verifies that the integrated process consistently produces conforming output. Together they support process validation.

    What this means in practice

    A well-known shorthand, but the structure varies - software validation and aseptic process validation each have their own variants.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2MDIC·1
    1. 1
      FDA Process Validation Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.