21 CFR 58
Good Laboratory Practice for Nonclinical Laboratory Studies · glp · good laboratory practice
FDA's GLP regulation — the quality system for nonclinical (animal/in-vitro) safety studies that support drug, device and food submissions.
21 CFR Part 58 governs nonclinical laboratory studies whose results are submitted to FDA in support of an IND, NDA, BLA, 510(k), PMA or food/colour additive petition. It mandates a Study Director, an independent Quality Assurance Unit, written protocols, full raw-data retention and a final report whose conclusions can be reconstructed from archived records.
GLP does not apply to clinical trials (that's GCP — 21 CFR 50, 56, 312, 812) or to routine QC testing of commercial product (that's cGMP — 21 CFR 211 Subpart I). Confusing the three is one of the most common 483 themes.
- 21 CFR Part 58
- OECD Principles of GLP
Free trial, no credit card, onboard in days, not months.