GLP Compliance in Preclinical Studies: Where Programmes Lose Data

What GLP does and does not cover

GLP is about the reconstructability of a study, not about scientific merit. It does not tell you whether your model was appropriate or your endpoints sensible; it tells a reviewer whether what you reported is what actually happened. It applies to non-clinical health and environmental safety studies intended to support a regulatory submission, which means discovery work is generally out of scope and pivotal toxicology is firmly in it. The most expensive misunderstanding in early-stage programmes is assuming that because a laboratory is competent, its data is submissible. Competence produces good science; GLP produces defensible science, and a regulator can only act on the second.

Where do programmes actually lose data?

Three controls decide the outcome. First, the study director: a single named individual with overall responsibility for the study, who must actually be in control of it. Where the director is nominal and a sponsor project manager is really directing the work, the study's integrity claim collapses. Second, the definition of raw data. If the study plan does not define what constitutes raw data — instrument output, worksheets, the electronic record, the printout — then nobody knows what must be retained, and the study cannot be reconstructed later. Third, the quality assurance unit, which must be independent of the personnel conducting the study. A QA function reporting to the operational manager it inspects is not a QA function.

What happens when a pivotal study cannot be defended?

The practical consequence is repetition, and the cost is rarely the study fee. Repeating a pivotal toxicology study consumes months of calendar time on the critical path to first-in-human dosing, and it consumes animals, which raises an ethical cost that regulators and ethics committees both weigh. The compounding problem is timing: the defect is usually discovered during submission review or a sponsor audit, long after the study closed and often after the laboratory relationship ended. This is why sponsor oversight of a contract laboratory matters more than the laboratory's certificates. The sponsor cannot delegate the consequence of an unusable study.

Frequently asked questions

Does discovery work need to be GLP?

Generally no. GLP applies to non-clinical safety studies intended to support a regulatory submission. Exploratory and screening work is normally conducted outside GLP, but the transition point should be a deliberate decision rather than something discovered later.

Is a GLP certificate from our contract laboratory enough?

No. A certificate evidences that a facility has been inspected against GLP; it says nothing about whether your specific study was conducted in compliance. Sponsor oversight, study-specific audits and review of the study plan remain your responsibility.

What is the difference between GLP and GCP?

GLP governs non-clinical safety studies, typically in laboratory and animal settings, and centres on study reconstructability. GCP governs clinical trials in human subjects and centres additionally on subject safety, informed consent and ethical oversight.

Sources

1. OECD Principles of Good Laboratory Practice, Organisation for Economic Co-operation and Development. oecd.org
2. 21 CFR Part 58 — Good Laboratory Practice for Nonclinical Laboratory Studies, US Food and Drug Administration. ecfr.gov

Pending scientific review. This briefing summarises published regulatory guidance and has not yet been signed off by a named subject-matter expert. Verify against the primary sources below before relying on it.

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