GLP vs GMP
The two “G”s people mix up — one governs studies, the other governs product.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
Good Laboratory Practice governs non-clinical safety studies — the toxicology and safety work that supports a regulatory submission — and centres on the integrity and reconstructability of study data. Good Manufacturing Practice governs how a product is actually made and controlled. They are frequently confused because both are “labs” and both stress data integrity, but they cover different stages and answer different questions.
| ASPECT | GLP | GMP |
|---|---|---|
| Governs | Non-clinical safety/toxicology studies | Manufacture and control of the product |
| US regulation | 21 CFR Part 58 | 21 CFR Parts 210 and 211 (drugs) |
| Core question | Can this study be trusted and reconstructed exactly? | Is every batch made to consistent, specified quality? |
| Key roles | Study Director (single point of study control), QAU | Quality unit; (EU) Qualified Person for release |
| Unit of work | The study (protocol → report), archived intact | The batch (record → release) |
| Where it applies | Safety studies supporting the submission, not the marketed product | Clinical-supply and commercial manufacturing |
| A QC lab under GMP? | Not GLP — a release-testing QC lab runs under GMP | Yes — routine QC testing of batches is a GMP activity |
GLP applies when you run non-clinical safety studies (e.g., toxicology) whose data will support a regulatory submission — the concern is that the study is credible and could be reconstructed years later.
GMP applies to making the product and to the QC testing that releases each batch — the concern is consistent, specified quality, batch after batch.
The tell that cuts through the confusion: GLP is about a study, GMP is about a batch. A quality-control lab testing release samples is doing GMP work, not GLP, even though it is a “lab.” GLP protects the integrity of the safety data behind an application; GMP protects the quality of the product a patient receives.
GLP vs GMP: frequently asked questions
Common questions on how GLP and GMP differ and when each applies.
Is a QC release-testing lab GLP or GMP?
GMP. GLP applies to non-clinical safety studies supporting a submission, not to routine quality-control testing of manufactured batches. A QC lab releasing product operates under GMP, even though it is a laboratory.
Do GLP and GMP both require data integrity?
Yes, but for different records. GLP protects the integrity and reconstructability of study data (protocol, raw data, final report, archive); GMP protects the integrity of batch records and QC data. ALCOA+ principles apply to both.
Which applies to clinical trial material?
GMP. Investigational medicinal products for clinical trials are manufactured under GMP (with specific provisions for IMPs). GLP governs the earlier non-clinical safety studies, not the manufacture of clinical supplies.
What is the Study Director in GLP?
The Study Director is the single point of study control under GLP — one named individual responsible for the technical conduct of a study and for the interpretation, analysis, documentation and reporting of results. GMP has no identical role; batch responsibility sits with the quality unit (and, in the EU, the Qualified Person for release).