Good Laboratory Practice
Non-clinical safety studies and their reconstructability.
What this page does not claim
Educational orientation — not a determination of regulatory applicability, compliance, validation scope, or organizational approval.
WHAT IT GOVERNS
Good Laboratory Practice is the quality system governing the conduct of non-clinical safety studies (OECD Principles of GLP; 21 CFR Part 58) — the organizational process and conditions under which studies are planned, performed, monitored, recorded, archived, and reported. Its single organizing goal is reconstructability: any GLP study must be reproducible from its raw data alone.
WHY IT MATTERS
GLP data supports the safety case that lets a molecule go into humans for the first time. A toxicology study that cannot be reconstructed from its raw data cannot support that decision — and a data-integrity failure in the GLP archive can unwind years of a development programme. GLP is where the reliability of the pre-clinical safety package is established.
KEY FOCUS AREAS
Study director & QAU independence
A single accountable Study Director for each study and an independent Quality Assurance Unit that inspects studies and reports to management — the structural separation that keeps studies honest.
The study plan & protocol
A signed, controlled study plan that defines the design, methods, and conduct before work begins, with amendments and deviations formally captured.
Raw data & reconstructability
Contemporaneous, attributable raw data — the primary record from which the final report is built and against which it can always be checked.
Test & reference item characterization
Identity, strength, purity, and stability of the test and reference items, so the study’s findings can be attributed to a known substance.
STANDARDS SPEQ DECODES · 8
Open the full library →WHAT INSPECTORS LOOK AT
- The QAU master schedule and study/facility inspection records
- Raw-data traceability from primary record to final report
- Equipment calibration, maintenance, and computerised-system control
- Archived records, retention, and the archivist’s control of access
RELATED DISCIPLINES
SECTORS THAT OPERATE UNDER GLP
GLP: frequently asked questions
Reference answers on Good Laboratory Practice — what it governs, what regulations define it, and what it requires.
What is Good Laboratory Practice (GLP)?
GLP is the quality system governing the conduct of non-clinical safety studies — the organizational process and conditions under which studies are planned, performed, monitored, recorded, archived, and reported. Its single organizing goal is reconstructability: any GLP study must be reproducible from its raw data alone.
What regulations govern GLP?
In the United States, GLP for non-clinical laboratory studies is set by 21 CFR Part 58. Internationally, the OECD Principles of Good Laboratory Practice provide the harmonised standard recognised across OECD member countries for the mutual acceptance of safety data.
What is the role of the Study Director and QAU in GLP?
GLP requires a single accountable Study Director for each study and an independent Quality Assurance Unit (QAU) that inspects studies and facilities and reports to management. This structural separation — the QAU is independent of the study conduct — is what keeps studies honest and reconstructable.