Good Clinical Laboratory Practice (GCLP)
The WHO/TDR standard for laboratories analysing specimens from clinical trials. GCLP bridges GCP and GLP: it applies GLP-style organisation, quality assurance, and record-keeping to trial-sample analysis so that laboratory data supporting clinical decisions is reliable, reconstructable, and protects trial subjects.
What this does not cover
stated in the document's own scope- Covers the analysis of specimens from clinical trials, not the conduct of the trial itself, which is governed by Good Clinical Practice (ICH E6).
- Applies to clinical-trial laboratories, not to nonclinical safety studies, which are governed by Good Laboratory Practice (OECD GLP / 21 CFR Part 58).
- Is WHO guidance, not law; its force comes from adoption by sponsors, trial frameworks, and national programmes.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
WHO Good Clinical Laboratory Practice (GCLP) is the standard for laboratories that analyse specimens from clinical trials. Published by WHO with the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), it fills the space between two established frameworks: Good Clinical Practice governs the conduct of the trial, and Good Laboratory Practice governs nonclinical safety studies, but neither squarely fits the analysis of trial samples. GCLP applies GLP-style organisation, quality assurance, documentation, and equipment and method control to that analysis, so that laboratory data supporting clinical decisions is reliable and reconstructable while trial-subject protections are maintained.
Scope & applicability
Laboratories performing analysis of specimens from clinical trials — safety testing, endpoint assays, and diagnostic support — whether in-house, central, or contracted, particularly where full GLP accreditation is neither required nor sufficient.
Legal basis & how it acquires force
WHO GCLP is a guidance document, not a statute — WHO issues it as a recommended standard rather than as enforceable law. It acquires practical force through adoption: sponsors and clinical-trial frameworks require trial-sample laboratories to work to GCLP, and national programmes and networks reference it in their quality requirements. It draws its principles from the OECD GLP framework and the ICH GCP framework, translating both into the specific setting of the clinical-trial laboratory rather than creating a new legal obligation of its own.
Document structure
| Part | Covers |
|---|---|
| Organisation and personnel | Laboratory management, defined responsibilities, and personnel training |
| Quality assurance | An independent quality-assurance function and its role in trial-sample analysis |
| Facilities, equipment, and materials | Suitable facilities, calibrated and maintained equipment, and reagent control |
| Standard operating procedures and methods | Documented procedures and validated or verified analytical methods |
| Records, reporting, and archiving | Data recording, reporting of results, and retention of records and specimens |
Key requirements
- Define laboratory organisation with a named responsible head and independent QA
- Validate analytical methods for their clinical-trial purpose before use
- Maintain specimen chain of custody from receipt through disposal
- Capture raw data contemporaneously with controlled corrections
- Retain records so any reported result can be fully reconstructed
Implementation tips
- Map each GCLP element to your existing GCP/GLP SOPs first — most gaps are coverage, not absence
- Make specimen identity checks a two-point verification at receipt and at analysis
- Keep reference-range derivations and method validation reports inspection-ready; they anchor result credibility
Revision notes
Published by WHO/TDR in 2009 and still the internationally cited GCLP reference. Widely used by sponsors and CROs as the audit standard for central and trial-site laboratories.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
GCLP is a deliberate bridge between ICH GCP (which governs how a clinical trial is conducted) and the OECD/GLP principles (which govern quality in the laboratory). It complements them rather than replacing either — a trial follows GCP, its safety studies follow GLP, and the laboratory analysing its clinical samples follows GCLP. It is widely used in international and resource-limited-setting trial networks where a common laboratory-quality reference is needed.
WHO GCLP (2009): frequently asked questions
Quick answers to common questions about WHO GCLP (2009).
What gap does WHO GCLP fill?
It sits between GCP, which governs the conduct of a clinical trial, and GLP, which governs nonclinical safety studies. Neither squarely covers the analysis of clinical-trial specimens, so GCLP applies GLP-style quality controls to that laboratory work.
Is WHO GCLP the same as GLP?
No. GLP (OECD / 21 CFR Part 58) governs nonclinical safety studies. GCLP takes GLP-style organisation, quality assurance, and documentation and applies them specifically to laboratories analysing samples from human clinical trials.
Is WHO GCLP legally binding?
No. It is a WHO guidance standard. It gains force through adoption — sponsors and trial frameworks require trial-sample laboratories to work to GCLP, and national programmes reference it in their quality requirements.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.