Episode 1: Process Validation Overview


In this episode, we have a general discussion about process validation – what it is, why we do it, and a general overview of Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ).

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Show Notes:

  • What is Process Validation?
    • GHTF defines as “establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements”
  • Why do we validate processes?
    • Decreased inspection costs
    • Decreased nonconforming material costs
  • History of Process Validation
    • GHTF Process Validation Guidance January 2004
      • Still heavily referenced today
      • Decision tree on validation (verify or validate)
      • Defines IQ/OQ/PQ
      • Special Processes that should be validated
        • Plastic injection molding
        • Sterilization
    • GHTF is defunct; IMDRF has taken over ownership of GHTF documents
      • Has not produced a new guidance for process validation
  • Is Validation Required?
    • Multiple standards and regulations
      • ISO 9001, ISO 13485, 21 CFR 820 Med Dev, 21 CFR 21
    • Pharmaceuticals
    • Medical Devices follow GHTF: If process output is not verifiable, validation required
      • Statistical sampling or 100% inspection
      • Special processes required to be validated
        • Plastic injection molding
        • Sterilization
  • Documentation
    • SOP
      • IQ/OQ/PQ
      • Running at risk
      • Material controls
      • Links to other systems (risk management, statistical sampling, change control, templates)
    • Each stage typically has a protocol and report document
      • Helpful to make these into templates to keep process output uniform
      • Ensure everyone is walking through the same thought pattern
    • Pre-approved protocols with acceptance criteria are key.
      • Executing protocols that aren’t approved make it look like your organization sets the bar at whatever level passes
    • Pre-approved protocols executed
    • Deviations (improper protocol execution, failures, etc) noted
      • Approved on separate form built into protocol
      • Approved in reports (preferred)
    • Reports that capture protocol execution results and make a determination if that stage passed or failed

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