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Schedule 1 GOOD LABORATORY PRACTICE PRINCIPLES (BASED ON SECTION II OF ANNEX I TO THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2004/10/EC)F1

  1. ITEST FACILITY ORGANISATION AND PERSONNEL
  2. IIQUALITY ASSURANCE PROGRAMME
  3. IIIFACILITIES
  4. IVAPPARATUS, MATERIALS AND REAGENTS
  5. VTEST SYSTEMS
  6. VITEST AND REFERENCE ITEMS
  7. VIISTANDARD OPERATING PROCEDURES
  8. VIIIPERFORMANCE OF THE REGULATORY STUDY
  9. IXREPORTING OF REGULATORY STUDY RESULTS
  10. XSTORAGE AND RETENTION OF RECORDS AND MATERIALS

Annotations

Textual amendments

F1

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