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Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies

This guidance provides detailed requirements for Good Laboratory Practice (GLP) regulations, focusing on the conduct of non-clinical laboratory studies intended to support applications for research or marketing permits for FDA-regulated products. It covers organizational structure, facilities, equipment, testing procedures, documentation, and quality assurance requirements.

  1. Establish independent Quality Assurance Unit
  2. Develop comprehensive Standard Operating Procedures
  3. Create master schedule of all GLP studies
  4. Implement proper documentation and archiving systems
  5. Ensure proper characterization and storage of test articles
  6. Establish proper animal care facilities and procedures
  7. Document personnel qualifications and training
  8. Develop protocols meeting all GLP requirements
  9. Implement proper specimen labeling procedures
  10. Establish computer system controls and audit trails
  11. Create procedures for protocol amendments and deviations
  12. Develop procedures for final report preparation and review

Key Considerations

Non-clinical testing

  • Study director must be designated for each non-clinical laboratory study
  • Written protocols required for all studies covered by GLPs
  • Test and control articles must be properly characterized
  • Raw data must be recorded and stored appropriately
  • Final reports must include all required elements specified in the guidance

Labelling

  • All specimens must be labeled with test system, study, nature and date of collection
  • Test articles must be labeled with storage conditions and expiration dates

Software

  • Computer systems must ensure data integrity and maintain audit trails
  • Standard operating procedures required for computer operations

Safety

  • Facilities must have appropriate separation of operations to prevent contamination
  • Animal care facilities must meet specified requirements
  • Safety testing of biological products must comply with GLPs

Other considerations

  • AAALAC: American Association for Accreditation of Laboratory Animal Care standards
  • Guide for the Care of Laboratory Animals

Original guidance

  • Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
  • HTML
  • Issue date: 1979-08-31
  • Last changed date: 2024-10-24
  • Status: FINAL
  • Official FDA topics: Radiation-Emitting Products, Clinical Trials, Medical Devices, Food & Beverages, Investigational New Drug Application (INDA), Pharmacology/Toxicology, Drugs, Animal & Veterinary, Compliance, Food & Color Additives, Biologics
  • ReguVirta summary file ID: 1de761c58636447a103a3f19cb9f1b08
This post is licensed under CC BY 4.0 by the author.