Good Clinical Laboratory Practice

Good Clinical Laboratory Practice governs the analysis of specimens generated in clinical trials (WHO and MHRA GCLP) — applying the reliability disciplines of GLP to the laboratory testing of clinical-trial samples. It bridges the gap between GCP, which governs the trial, and the laboratory rigor those trial endpoints depend on.

Clinical-trial conclusions frequently ride on laboratory results — a biomarker, a PK concentration, a safety assay. If the lab that generated those numbers cannot demonstrate validated methods and an intact chain of custody, the endpoint they support is exposed. GCLP is what makes clinical-trial lab data as defensible as the trial it feeds.

Methods validated for their intended use — accuracy, precision, specificity, and range — before they generate data that will support a trial conclusion.

Documented handling, storage, and tracking of samples from collection to analysis, so every result can be tied to a known specimen under known conditions.

Analytical instruments qualified, calibrated, and maintained, with the records to prove they were fit at the time of use.

A quality system — SOPs, training, and QA oversight — that holds the clinical laboratory to a reconstructable, auditable standard.

• ›Method validation records covering the intended analytical use
• ›Sample handling, storage conditions, and chain-of-custody documentation
• ›Result traceability from instrument output to reported value
• ›Personnel training and demonstrated competence for the assays run

Derived from the 1 standard SPEQ decodes for this discipline.