GLP vs. GMP: What's the Difference, and Which Do You Need?
GLP and GMP sound alike, share a philosophy, and get confused constantly. They're different regulations for different activities — and many organizations need both, for different operations.
The one-sentence version
GLP (Good Laboratory Practice, FDA 21 CFR Part 58) governs nonclinical laboratory studies — safety testing done before human trials or product registration. GMP (Good Manufacturing Practice, FDA 21 CFR Parts 210/211) governs manufacturing — making the actual drug or device consistently and cleanly.
Side by side
| GLP | GMP | |
|---|---|---|
| Applies to | Nonclinical safety studies (tox, pharmacology, environmental) | Manufacturing, processing, packing, holding of drugs/devices |
| US regulation | 21 CFR Part 58 | 21 CFR Parts 210/211 (drugs) |
| International | OECD GLP Principles | WHO/PIC/S GMP, EU GMP |
| QA model | Independent QA unit audits studies | Quality unit approves/rejects product and processes |
| Typical “customer” | Regulatory submissions (IND, NDA, EPA registration) | Marketed product quality and patient safety |
When you need both
Pharma companies routinely run GLP tox studies and manufacture under GMP — different buildings, different QA functions, sometimes different consultants. Analytical labs testing both nonclinical samples (GLP) and commercial product (GMP) need to keep the two quality systems distinct, even when the bench work looks similar.
Consultant overlap
Many GxP consultants work across GLP and GMP, but the audit checklists differ. When hiring, confirm the firm audits your regulation specifically — a GMP auditor winging a GLP facility audit will miss GLP-specific expectations like study-director authority and archive requirements. Our directory lists firms by their actual GLP services.
Related guides
- What Is GLP? Good Laboratory Practice Explained Without the Jargon
- How to Choose a GLP Consultant: 9 Questions Before You Sign
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