Post

Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies

This guidance addresses the use and management of whole slide imaging (WSI) in histopathology assessment and pathology peer review for GLP-compliant nonclinical toxicology studies using non-human specimens. It specifically focuses on documentation practices during generation, use, and retention of whole slide images.

  1. Develop and implement written procedures for WSI processes
  2. Establish validation protocol for WSI system
  3. Implement data protection and security measures
  4. Create documentation system for technical image processing modifications
  5. Set up proper archival system for both glass slides and WSI files
  6. Update pathology report templates to include WSI usage documentation
  7. Establish training program for staff using WSI systems
  8. Implement version control system to ensure long-term accessibility of archived images
  9. Create procedures for file access and exchange control
  10. Establish compliance verification process with 21 CFR Part 11 requirements

Key Considerations

Non-clinical testing

  • WSI should include all elements from glass slides needed for histopathological examination
  • Glass slides must be retained as study specimens after study finalization
  • Original WSI files must be retained if used to generate raw data
  • Technical image processing modifications must be documented and retained
  • Pathologists should not permanently alter original WSI files

Software

  • WSI system (software and hardware) must be validated for intended use
  • Written procedures for software management must be in place
  • Compliance with 21 CFR part 11 for electronic records is required

Cybersecurity

  • WSI files must be protected to prevent loss or alteration
  • Chain of custody must be maintained
  • Access control must be implemented
  • Data systems and transmission must be secured

Labelling

  • Pathology reports must state whether glass slides or WSI were used for evaluation
  • Peer review statements must indicate whether glass slides or WSI were reviewed

Other considerations

  • 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
  • 21 CFR Part 11: Electronic Records; Electronic Signatures

Original guidance

  • Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
  • HTML / PDF
  • Issue date: 2023-05-24
  • Last changed date: 2024-10-01
  • Status: FINAL
  • Official FDA topics: Tobacco, Medical Devices, Pharmacology/Toxicology, Drugs, Biologics
  • ReguVirta summary file ID: d6a624864ca1f9b79656ecfefccf5fb3
This post is licensed under CC BY 4.0 by the author.