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Part I INSPECTION PROCEDURES

  1. 1Pre-inspection
  2. 2Starting conference
  3. 3Organisation and personnel
  4. 4Quality assurance programme
  5. 5Facilities
  6. 6Care, housing and containment of biological test systems
  7. 7Apparatus, materials, reagents and specimens
  8. 8Test systems
  9. 9Test and reference items
  10. 10Standard operating procedures
  11. 11Performance of the study
  12. 12Reporting of study results
  13. 13Storage and retention of records

Notes on Schedule 2

Textual amendments

F1

Words in Sch. 2 heading substituted (27.4.2004) by The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(e)