Good Laboratory Practice (GLP)
Defined by FDA (21 CFR Part 58)
StandardAudit Scope
Non-clinical laboratory studies: organization, personnel, facilities, equipment, testing facilities operation, test/control articles, protocols, records, reporting.
What It Proves
Laboratory conducts non-clinical safety studies subject to FDA GLP regulations (21 CFR Part 58). Primarily relevant for safety studies submitted to FDA.
What It Does Not Prove
GLP applies to non-clinical safety studies, NOT routine quality control testing. There is no FDA-issued GLP certification — compliance is asserted by the laboratory and examined via FDA inspection of specific studies, not independently certified. GLP compliance is stricter and more expensive than typical supplement testing; it's relevant for NDI notifications and safety studies, not routine COA work.
How Vendors Report It
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