Good Laboratory Practice

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.

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.

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.

A signed, controlled study plan that defines the design, methods, and conduct before work begins, with amendments and deviations formally captured.

Contemporaneous, attributable raw data — the primary record from which the final report is built and against which it can always be checked.

Identity, strength, purity, and stability of the test and reference items, so the study’s findings can be attributed to a known substance.

• ›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

Derived from the 5 standards SPEQ decodes for this discipline.