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    Process Validation

    Establishing documented evidence that a process consistently produces conforming output.

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

    Definition

    Process validation per GHTF/SG3 covers Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to demonstrate process capability for specifications that cannot be fully verified by subsequent inspection or test.
    What the regulation says
    Process validation is a key requirement for medical device manufacturers, as outlined by regulatory bodies like the FDA in 21 CFR part 820.75 and the EU MDR in Annex I, Section 10.2. This involves establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. For sterile devices, demonstrating sterility assurance through validation is critical, often referencing standards like ISO 11137 for radiation sterilization or ISO 17665 for moist heat sterilization.

    What this means in practice

    Sterilization, injection molding, and software-controlled assembly are common validated processes.

    Examples

    • A manufacturer validates an injection molding process to ensure that each molded component consistently meets critical dimensional and material property specifications.
    • A medical device company validates its sterilization process using ethylene oxide to confirm that all devices achieve the required sterility assurance level.
    • A pharmaceutical company validates its aseptic filling process to ensure that each vial is filled accurately and remains free from microbial contamination.
    Common pitfalls
    • •Confusing process validation with design validation, which focuses on validating the device design meets user needs and intended uses.
    • •Failing to revalidate a process after significant changes to equipment, materials, or methods.
    • •Not adequately documenting all validation activities, including protocols, results, and deviations.
    • •Overlooking the need to validate supporting processes, such as cleaning or software used in manufacturing.
    • •Treating process validation as a one-time event rather than an ongoing activity through process monitoring and control.

    Frequently asked questions

    The primary goal is to ensure that a manufacturing process consistently produces a product that meets its predetermined specifications and quality attributes.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    GHTF/IMDRF·1ISO·1FDA·1
    1. 1
      GHTF SG3 Process Validation Guidance
      Verified
      GHTF/IMDRFimdrf.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

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