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Part B REVISED GUIDANCE FOR THE CONDUCT OF TEST FACILITY INSPECTIONS AND STUDY AUDITS

United Kingdom

Original text. Later amendments are not shown.

  1. Introduction
  2. Definitions of terms
  3. Test facility inspections
  4. Inspection procedures
  5. Starting conference
  6. Organisation and personnel
  7. Quality assurance programme
  8. Facilities
  9. Care, housing and containment of biological test systems
  10. Apparatus, materials, reagents and specimens
  11. Test systems
  12. Physical and chemical systems
  13. Biological test systems
  14. Test and reference substances
  15. Standard operating procedures
  16. Performance of the study
  17. Reporting of study results
  18. Storage and retention of records
  19. Study audits
  20. Completion of inspection or study audit