Examples
Worked examples
- Is an instance
A contract bioanalytical laboratory running PK/PD sample analysis for a Phase I first-in-human drug trial operates under GCLP: it maintains GLP-style method validation and raw-data audit trails, but layers on GCP-style chain-of-custody linking every sample back to a specific consented trial subject and visit -- something a standard preclinical GLP toxicology lab has no equivalent requirement for.
- Is an instance
A central laboratory processing biomarker samples across multiple international sites for a multi-site oncology trial follows GCLP so that data generated in different countries is produced to one harmonized quality standard, supporting the RQA/WHO rationale for GCLP as an internationally portable framework, particularly for laboratories in settings (including many low- and middle-income countries) where neither a formal GLP nor GCP inspection regime independently covers trial-support laboratory work.
Counter-examples
Looks similar, but isn't
- Not an instance
A toxicology laboratory running a preclinical animal safety study to support an IND submission is governed by GLP (21 CFR Part 58) alone, not GCLP -- there is no human clinical trial subject or sample chain-of-custody-to-a-consented-participant requirement, because the study is non-clinical.
- Not an instance
A clinical trial site's investigator and coordinating staff obtaining informed consent, administering the investigational product, and recording adverse events operate under GCP (ICH E6) alone -- GCP itself imposes no laboratory quality-system requirements, which is precisely the gap GCLP was created to close for the laboratories those sites send samples to.
Editorial commentary
Good Clinical Laboratory Practice (GCLP) is a distinct quality standard for laboratories that analyze human-derived samples collected in clinical trials — above all bioanalytical and pharmacokinetic (PK) sample analysis, but also biomarker assays and other clinical-trial-support laboratory testing. GCLP is not a subset or informal blend of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) — it is its own published guideline, developed specifically because neither existing standard, on its own, covers a clinical-trial-support laboratory’s actual work.
Why GCLP exists: the gap between GCP and GLP
GCP (codified internationally as ICH E6) governs how a clinical trial itself is designed, conducted, monitored, and reported — informed consent, investigator responsibilities, adverse-event reporting, trial-site record keeping. It says essentially nothing about laboratory operations: it does not specify how an analytical method must be validated, how equipment must be qualified, or how raw instrument data must be retained.
GLP, by contrast (in the US, 21 CFR Part 58, and internationally the OECD Principles of GLP), was written for nonclinical laboratory studies — preclinical animal toxicology and safety testing submitted to support an IND, NDA, BLA, or device application. GLP’s study-director/quality-assurance-unit structure and raw-data-integrity discipline are exactly the kind of rigor a bioanalytical laboratory needs, but GLP’s own scope explicitly excludes studies involving human clinical trial subjects.
That left a real gap: a laboratory receiving blood, plasma, or biomarker samples from a live clinical trial had no single standard that combined GLP-grade laboratory data-integrity discipline with GCP-grade human-subject sample traceability (linking every result back to a specific consented, identifiable trial participant and visit, under the trial’s own protocol and consent constraints). GCLP was created to fill that gap.
Origin and governing bodies
The first GCLP guideline was produced in 2002 by the Research Quality Association (RQA) — at the time operating under its earlier name, the British Association of Research Quality Assurance (BARQA); the organisation renamed itself to RQA in December 2012 to reflect a broader, more international remit. The guideline was framed as “An International Quality System for Laboratories which undertake the analysis of samples from clinical trials,” and RQA continues to publish and update GCLP guidance (its current GCLP eBooklet, authored by Tim Stiles and Vanessa Grant, was published January 2012).
Since then, GCLP guidance has been separately issued or adopted by other bodies working from the same core principles, most notably the World Health Organization (through its Special Programme for Research and Training in Tropical Diseases, WHO-TDR, which produced GCLP guidance aimed particularly at laboratories in low- and middle-income countries supporting international trial networks) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which has issued its own GCLP guidance. There is no single global regulatory GCLP requirement in the way 21 CFR Part 58 is a binding US federal regulation for GLP — GCLP functions more like an internationally recognized quality framework that sponsors, CROs, and laboratories adopt (and are audited against) by agreement and industry convention, including as a contractual or funder expectation on a given trial.
What a GCLP quality system covers
A laboratory operating to GCLP typically documents and controls:
- Facility and equipment qualification — installation, operational, and performance qualification of analytical instruments, consistent with GLP-style equipment control.
- Personnel training and competency records — documented, current training for every staff member performing or supervising trial-sample analysis.
- Standard operating procedures (SOPs) — written, version-controlled procedures for every step from sample receipt through result reporting.
- Sample chain-of-custody and traceability — an unbroken record linking every sample to a specific, identifiable (but appropriately confidentiality-protected) clinical trial subject, visit, and protocol — the clinical-trial-specific element GLP alone does not require.
- Analytical method validation — documented evidence that a bioanalytical or biomarker assay method performs as intended before it is used to generate trial data.
- Raw data integrity and retention — audit-trailed, attributable, contemporaneous raw data, retained per the trial’s protocol and applicable regulatory retention periods.
- Independent quality assurance — a QA function, separate from the staff generating the data, that audits the laboratory’s compliance with its own SOPs and the GCLP standard.
GCLP, GCP, and GLP compared
The three standards are complementary rather than competing, and a given clinical trial typically involves all three operating on different parts of the same program simultaneously:
- GCP (ICH E6) governs the clinical trial itself — informed consent, investigator conduct, monitoring, adverse-event reporting — at the trial site level, not the laboratory.
- GLP (21 CFR Part 58 / OECD Principles) governs nonclinical, preclinical laboratory studies — typically animal toxicology and safety studies conducted before human trials begin, with no human clinical trial subject or sample chain-of-custody-to-a-consented-participant element.
- GCLP governs the laboratory analysis of samples that originate from a clinical trial — combining GLP-grade laboratory data-integrity discipline with GCP-grade human-subject sample traceability. It is the standard specifically for bioanalytical/PK laboratories, central laboratories, and biomarker labs supporting a clinical trial, not for the trial site itself and not for preclinical laboratory work.
A sponsor or CRO auditing a bioanalytical laboratory supporting a clinical trial will typically audit against GCLP specifically, rather than treating a GLP certificate or a site’s GCP compliance as sufficient evidence that the laboratory’s own sample-handling and data-integrity practices meet the standard the trial actually needs.
Related terms
See also ICH GCP (Good Clinical Practice) and Good Laboratory Practice (GLP) for the two standards GCLP sits between.
Machine-readable encodings
Use in your systems
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