How to Write a GLP Final Report
Produce the document the study exists to produce, with its compliance statement intact.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
The final report is the study. Everything else — the plan, the raw data, the inspections — exists so that this document can be trusted. Two elements make it a good laboratory practice report rather than a scientific write-up: the study director’s dated compliance statement, and the quality assurance statement. Neither can be added convincingly at the end if the study was not run to support them.
- 1
Identify the study, the test item and the facilities unambiguously
Name the study, the test and control articles with their characterisation, the sponsor, the test facility and any test sites, and the dates of the in-life phase. A reader who cannot tell which material and which facility produced the data cannot use the report for anything.
- 2
Describe methods as performed, not as planned
Where conduct differed from the plan, describe what was done and reference the deviation. A methods section copied from the study plan is a description of an intention, and the difference between intention and conduct is exactly what a reviewer is looking for.
- 3
State every deviation and assess its effect on the study
Deviations are listed with their impact assessed, not merely logged. An unexplained deviation invites the reader to assume the worst about it; an assessed one, even a serious one, is a study that knows what happened to it.
- 4
Present the data so the conclusions can be traced back
Summary tables should be traceable to the individual data, and the individual data to the raw records. A conclusion that cannot be followed back to its raw data is an assertion, whatever the quality of the underlying work.
- 5
Attach the contributing scientists’ reports rather than paraphrasing them
Pathology, analytical chemistry and any delegated phase are reported by the person who did the work, signed and dated. Paraphrasing a contributing report into the main text puts the study director’s voice on someone else’s findings.
- 6
Sign the compliance statement, naming the deviations
The study director signs and dates a statement that the study complied with the applicable principles, identifying any deviation and its effect. Signing a clean statement over a study with unresolved deviations is the most serious integrity failure available in this discipline.
- 7
Include the quality assurance statement and control amendments
The unit’s statement lists the inspections and reporting dates. After the report is signed, any change is a formal amendment identifying what changed, why, and by whom — a corrected report reissued silently destroys the traceability the signature established.
- !A methods section copied from the study plan, describing the intention rather than the conduct.
- !Deviations listed without an impact assessment, leaving the reader to assume the worst.
- !Contributing scientists’ findings paraphrased into the main text instead of attached as signed reports.
- !A signed report changed without a formal amendment, breaking the traceability the signature created.
How to Write a GLP Final Report: frequently asked questions
Common questions on write a glp final report.
What does the compliance statement actually commit the director to?
That the study was conducted in accordance with the applicable principles, and that any deviation from them is identified along with its effect on the study. It is a personal, dated attestation. A director who signs a clean statement over unresolved deviations has committed the most serious integrity failure this discipline recognises.
Can a signed final report be changed?
Only by a formal amendment that identifies what changed, why, and who authorised it, leaving the original visible. Reissuing a corrected version silently destroys the traceability the original signature created, and it is discoverable — reviewers compare versions.
Why attach contributing reports rather than summarise them?
Because the pathologist and the analytical chemist are the authors of their findings and sign for them. A summary in the director’s voice puts one signature over another person’s scientific judgement, and it removes the reader’s ability to see the finding as its author stated it.