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.
What You Need to Know? 👇
What are the key differences between GLP requirements for short-term versus long-term studies?
While GLPs apply equally to all nonclinical laboratory studies regardless of duration, short-term studies (less than 6 months) need less frequent quality assurance unit inspections compared to long-term studies (more than 6 months) which require inspection every 3 months.
Do medical device functionality tests fall under GLP regulations?
No, engineering tests and in vitro functionality tests for medical devices are not covered by GLPs. Only safety studies that assess potential adverse tissue reactions or toxic responses from implantable devices or their components fall under GLP requirements.
What are the quality assurance unit inspection requirements for acute studies?
For studies lasting less than 4 weeks, each final report must be reviewed by the quality assurance unit for accuracy. A random sampling approach can be used for in-process phases, ensuring each critical phase is monitored across multiple studies.
Can foreign laboratory data be accepted without GLP compliance monitoring?
Foreign laboratories conducting studies submitted to FDA must comply with the same GLP requirements as U.S. laboratories. FDA maintains the policy of not accepting data from any laboratory that refuses to permit inspection of its facilities.
What constitutes “raw data” in computerized systems for GLP compliance?
Raw data includes transcribed dictation that has been proofread and corrected for typographical errors. Computer systems must have documented procedures ensuring exact data transfer, and all changes to permanent files must be recorded with appropriate audit trails.
How often should laboratories expect GLP inspections from FDA?
Routine surveillance inspections occur at least once every two years, with more frequent inspections possible based on previous findings. Additional inspections may be required when auditing specific studies submitted for marketing applications or following serious adverse findings.
What You Need to Do 👇
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 ID: 1de761c58636447a103a3f19cb9f1b08