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.
Recommended Actions
- Establish independent Quality Assurance Unit
- Develop comprehensive Standard Operating Procedures
- Create master schedule of all GLP studies
- Implement proper documentation and archiving systems
- Ensure proper characterization and storage of test articles
- Establish proper animal care facilities and procedures
- Document personnel qualifications and training
- Develop protocols meeting all GLP requirements
- Implement proper specimen labeling procedures
- Establish computer system controls and audit trails
- Create procedures for protocol amendments and deviations
- 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
- Quality Assurance Unit must be independent from study conduct
- Archives must maintain records for specified retention periods
- Standard Operating Procedures required for all aspects of facility operations
- Master schedule required listing all GLP studies
- Personnel must have appropriate education, training and experience
Relevant Guidances
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
- Histopathology Peer Review in Nonclinical Toxicology Studies
- Animal Testing for Medical Device Safety and Performance Evaluation
Related references and norms
- 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.