01
Organization & Personnel
Define roles, responsibilities, and authority across the test facility.
✓ OECD-Aligned Compliance Resource
The complete guide to Good Laboratory Practice
Master the principles, documentation, and quality assurance frameworks that make non-clinical safety studies trustworthy, reproducible, and regulator-ready.
10
OECD Principles of GLP
8
Core compliance areas
1978
Year FDA formalized GLP
30+
OECD member countries
Compliance ReadyFDA · OECD · EPA · EMA
The Framework
Eight principles that define GLP compliance
From organizational structure to archive retention, these interconnected principles ensure every non-clinical study produces data that regulators can trust.
02
Quality Assurance Program
Independent oversight that audits every phase of the study lifecycle.
03
Facilities & Equipment
Suitable, calibrated, and validated environments and instruments.
04
Standard Operating Procedures
Written procedures that standardize every repeated activity.
05
Test & Reference Systems
Proper handling, identification, and documentation of test systems.
06
Study Performance & Protocol
A written, approved protocol governs every study from start to finish.
07
Reporting & Records
A complete, accurate final report reflects the raw data faithfully.
08
Archives & Retention
Secure, retrievable storage of all study materials and records.
⚠ Critical Compliance Reminders
Never back-date or overwrite raw data — this is a critical violation.
Inspections can occur without notice — stay audit-ready at all times.
The Study Director and QAU must always remain independent roles.
Knowledge Base
The GLP guide
In-depth articles covering every aspect of Good Laboratory Practice — from foundational concepts to audit preparation.
What Is Good Laboratory Practice?
GLP is a quality system covering the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived.
Read article →GLP vs. GMP vs. GCP: Understanding the GxP Family
The "X" in GxP stands for the domain — Laboratory, Manufacturing, or Clinical. Each framework addresses a different stage of the product lifecycle.
Read article →The Study Director: Single Point of Control
The Study Director is the central figure in GLP — the one individual who bears overall responsibility for the scientific conduct of the study and the final report.
Read article →The Quality Assurance Unit: Independent Oversight
The QAU operates independently from study personnel to audit, inspect, and verify that GLP principles are followed at every stage.
Read article →Writing Effective Standard Operating Procedures
SOPs are the written backbone of GLP. Poorly written procedures create ambiguity, deviations, and non-compliance findings.
Read article →Data Integrity and ALCOA+ Principles
ALCOA+ expands the original FDA data integrity framework to ensure every recorded data point is trustworthy from creation to archive.
Read article →Preparing for a Regulatory Facility Inspection
Regulatory authorities inspect GLP facilities to verify compliance. Preparation, organization, and a clear inspection protocol are essential.
Read article →Validating Computerized Systems under GLP
Laboratory software — from LIMS to spreadsheets — must be validated before use and maintained under change control.
Read article →Self-Assessment Tool
GLP compliance checklist
Run through this interactive checklist to gauge your facility's readiness. Check off each item to track your progress.
0 of 15 items complete0%
Outstanding — your facility is inspection-ready across all core areas.
Organization
Personnel
Documentation
Facilities
Study Conduct
Reporting
Archives
Audit
Common Questions
Frequently asked questions
Clear answers to the most common questions about Good Laboratory Practice.
GLP is a regulatory framework focused on the quality and integrity of non-clinical safety studies submitted to regulators. ISO 17025 is a general standard for the competence of testing and calibration laboratories. A lab may hold both, but they serve different purposes: GLP ensures study reliability for regulatory submission, while ISO 17025 ensures technical competence for any testing.
In most regulated industries — pharmaceuticals, pesticides, food additives, industrial chemicals — GLP compliance is mandatory for non-clinical safety studies submitted to regulatory authorities. The specific regulations vary by country and agency (FDA, OECD, EPA), but the OECD Principles of GLP are the most widely accepted international standard.
SOPs should be reviewed on a defined schedule, typically every one to two years, or sooner if a process changes. The review date should be documented on the SOP itself. Even if no changes are needed, the review confirms the procedure remains current and accurate.
Inspectors issue observations categorized by severity. The facility must respond with a corrective and preventive action (CAPA) plan within a specified timeframe. Serious or repeated deficiencies can lead to disqualification of the facility, rejection of study data, or regulatory enforcement action.
Generally, no. GLP applies to non-clinical safety studies intended for regulatory submission. Academic basic research is not bound by GLP. However, many academic labs adopt GLP-like practices to improve data quality, especially when their work may later support regulatory filings.
No. A fundamental principle of GLP is the independence of the Quality Assurance Unit from the study personnel. The Study Director cannot also serve as QAU for their own study, as this would eliminate the independent oversight that GLP requires.