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.
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.
- 01Define laboratory organisation with a named responsible head and independent QA
- 02Validate analytical methods for their clinical-trial purpose before use
- 03Maintain specimen chain of custody from receipt through disposal
- 04Capture raw data contemporaneously with controlled corrections
- 05Retain records so any reported result can be fully reconstructed
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.
WHO GCLP (2009): frequently asked questions
Quick answers to common questions about WHO GCLP (2009).
What is WHO GCLP (2009)?
WHO GCLP (2009) — Good Clinical Laboratory Practice (GCLP) — is a guideline issued by the World Health Organization. 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.
Who does WHO GCLP (2009) apply to?
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.
What are the key requirements of WHO GCLP (2009)?
WHO GCLP (2009) requires, among other things: 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.
When was WHO GCLP (2009) last updated?
The current version of WHO GCLP (2009) dates from January 2009. 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.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When WHO GCLP (2009) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.