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    Quality & RiskQuality SystemVMP

    Validation Master Plan

    Top-level document describing the manufacturer's overall approach to qualification and validation activities.

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

    Definition

    A VMP defines scope, responsibilities, methodology, acceptance criteria, and deliverables across equipment qualification (IQ/OQ/PQ), process validation, computer system validation, and cleaning validation activities.

    What this means in practice

    A well-maintained VMP makes inspection navigation dramatically easier and is expected by auditors at most established manufacturers.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    PIC/S·1FDA·1ISO·1
    1. 1
      PIC/S PI 006
      Verified
      PIC/Spicscheme.org
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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