GLP Study Conduct: Study Director & QAU
Good Laboratory Practice governs the non-clinical safety studies — toxicology, safety pharmacology, and the like — whose results regulators rely on to let a compound into humans. Its central and most misunderstood point is that GLP is not a standard of scientific merit; it is a standard of *organisation and integrity*. GLP does not ask whether the study was clever. It asks whether the study was planned, performed, monitored, recorded, archived, and reported under conditions that let an inspector, years later, reconstruct exactly what was done and trust that the reported results are what actually happened.
What an explainer is not
A topic explainer is SPEQ’s synthesis of what a practice involves, cited to the standards that govern it. It does not reproduce their text, and it does not determine which of them apply to your product or process.
[ POSITION IN THE FRAMEWORK ]
7 DIMENSIONS · 20 LINKSGLP governs the integrity and reconstructability of non-clinical safety studies — not their science — across the laboratory and documentation disciplines, held together by the single Study Director and an independent QAU.
06 · QUALITY MATURITY — GLP STUDY CONDUCT: STUDY DIRECTOR & QAU, REACTIVE TO ADAPTIVE
Studies run without a clearly single Study Director; raw data live on scrap sheets and the QAU, if it exists, reports to the study team.
A Study Director and QAU are named and SOPs exist, but QAU independence is nominal and raw-data traceability is patchy.
One Study Director controls each study, the QAU inspects critical phases and audits reports to raw data reporting to management, and the archive is controlled.
QAU findings and deviation trends inform study conduct and training before an inspection surfaces them.
Integrity is built in — attributable, contemporaneous raw data, a robust archive, and the Director/QAU separation make every study reconstructable years later.
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07 · REGULATORY & EVIDENCE
GOVERNING STANDARDS · 3
Derived from the 3 standards SPEQ maps to this subject, across 3 regulatory bodies: FDA, OECD, EC.
RECORDS & OBJECTIVE EVIDENCE
- Approved study protocols signed by the Study Director
- Contemporaneous, attributable raw data traceable to the final report
- QAU inspection records and the master schedule of studies
- The final report with the Study Director's statement that it reflects the raw data
- Archive records showing controlled retention of data, samples, and specimens
COMMON INSPECTION FINDINGS
- More than one, or no clearly single, Study Director for a study
- QAU reporting to the study team rather than to management
- Final-report results not traceable to raw data
- Deviations from protocol neither recorded nor justified
- Archive conditions or retention inadequate to reconstruct a study
What GLP governs — and the misconception at its centre
GLP applies to non-clinical health and environmental safety studies. In the United States it is set by 21 CFR Part 58; the OECD GLP Principles provide the internationally harmonised version that lets a study run in one country be accepted by regulators in another; the EU implements equivalent principles through Directive 2004/10/EC. Together they define the facility, personnel, equipment, and documentation conditions under which a safety study must be conducted.
The misconception worth correcting up front is that GLP means good science. It does not. A GLP study can use a scientifically weak design; a brilliant study can be conducted entirely outside GLP. What GLP guarantees is *integrity and reconstructability* — that the data are attributable, contemporaneous, and traceable, and that the final report faithfully reflects the raw data. Regulators separate the two questions deliberately: GLP assures the record; scientific review judges the science.
The Study Director — single point of study control
Every GLP study has one Study Director, and the role is the load-bearing element of the whole system. The Study Director is the single point of study control: one named individual with overall responsibility for the technical conduct of the study and for the interpretation, analysis, documentation, and reporting of results. There is exactly one per study, by design — accountability that can be split cannot be inspected.
The Study Director approves the protocol, ensures every procedure follows it (recording and justifying any deviation), confirms that the systems and personnel are qualified, and signs the final report — the signature that formally attests the report reflects the raw data. When an inspector reconstructs a study, they reconstruct the Study Director’s decisions.
The Quality Assurance Unit — independence by design
GLP requires a Quality Assurance Unit (QAU) that is organisationally independent of the people running the study. Independence is the point: the QAU inspects the study — critical phases, the facility, the records — and audits the final report against the raw data, and it reports to management, not to the Study Director whose work it is checking. A QAU that answered to the study team would be auditing its own boss.
The QAU maintains the master schedule of all studies, inspects at a defined frequency, and issues statements of the inspections performed and findings reported. This separation — the person accountable for the science (Study Director) distinct from the function that verifies compliance (QAU) — is the structural feature that makes a GLP claim credible, and it is the first thing an inspection tests.
Protocol, raw data, and the archive: reconstructability in practice
GLP runs on a documented chain: an approved protocol defines what will be done; raw data capture what was actually observed, contemporaneously and attributably; standard operating procedures govern how each routine task is performed; and the final report presents the results with the Study Director’s attestation that it reflects those raw data. Raw data are the ground truth — a result that cannot be traced back to its raw data does not exist for GLP purposes.
The archive closes the loop. GLP requires records, samples, and specimens to be retained under controlled, secure conditions for defined periods so that a study can be reconstructed long after it ends — the point at which a compound’s safety is questioned may be a decade after the study was reported. Archive integrity, raw-data traceability, and the Study Director/QAU separation are exactly the areas where GLP inspections concentrate, because they are what make the whole record trustworthy.
FREQUENTLY ASKED
What is Good Laboratory Practice (GLP)?
GLP is the quality system governing how non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. It assures the integrity and reconstructability of the data regulators rely on — set by 21 CFR Part 58 in the US, the OECD GLP Principles internationally, and Directive 2004/10/EC in the EU.
Is GLP about good science?
No — and this is the most common misunderstanding. GLP governs the organisation, conduct, and documentation of a study, not the scientific quality of its design. A GLP study can be scientifically weak, and excellent science can be done outside GLP. GLP guarantees that the reported results faithfully reflect what was actually done.
What does a GLP Study Director do?
The Study Director is the single point of study control: one named individual with overall responsibility for a study’s technical conduct, interpretation, documentation, and reporting. There is exactly one per study. The Study Director approves the protocol, ensures it is followed, and signs the final report attesting it reflects the raw data.
What is the Quality Assurance Unit (QAU)?
The QAU is an organisationally independent function that inspects GLP studies and audits final reports against raw data, reporting to management rather than to the study team. Its independence from the Study Director is the structural feature that makes a GLP claim credible.