CMC & ManufacturingLast reviewed May 2026

Good Laboratory Practice(GLP)

The quality system covering the organizational process and conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, and reported.

Usage Examples

The pivotal 28-day tox study was conducted under GLP at a qualified facility.
The QAU reviewed the study report and certified compliance per 21 CFR 58.185.
A BIMO inspection identified Form 483 observations on raw data retention.

What is GLP?

Good Laboratory Practice (GLP) is a quality management system required for nonclinical safety studies that support regulatory submissions. In the US, GLP is codified at 21 CFR Part 58 and applies to nonclinical laboratory studies used to support applications for research or marketing permits. OECD GLP principles apply internationally and are equivalent in substance.

GLP requires defined organizational responsibilities (study director, sponsor, testing facility management, QAU), documented standard operating procedures, study protocol and amendment control, facility and equipment qualification, test and reference item characterization, specimen handling and retention, and a detailed final report with a Quality Assurance Unit (QAU) statement. Records must be preserved for specified periods (typically 5-10 years) and available for FDA inspection.

GLP does not apply to all nonclinical work — exploratory, mechanistic, or hypothesis-generating studies may be non-GLP by design. But pivotal safety studies used to support first-in-human dosing, toxicology, and carcinogenicity must be GLP to be accepted by regulators. FDA inspects GLP facilities through the Bioresearch Monitoring (BIMO) program, and Form 483 observations in GLP facilities can delay associated IND submissions.

Regulatory Context

This term appears most often in cmc & manufacturing workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 58, OECD GLP.

FDAICHHealth Canada

When This Matters

The pivotal 28-day tox study was conducted under GLP at a qualified facility.
The QAU reviewed the study report and certified compliance per 21 CFR 58.185.
A BIMO inspection identified Form 483 observations on raw data retention.

Common Mistakes

Failing to align CMC change narratives with current CFR/ICH expectations.
Submitting incomplete control strategy documentation.
Separating manufacturing and regulatory review cycles too late in execution.

Related Regulations

21 CFR 58OECD GLP

Frequently Asked Questions

Pivotal nonclinical safety studies intended to support regulatory submissions: toxicology, safety pharmacology, and ADME studies that go into the IND or BLA safety assessment. Exploratory, screening, mechanistic, or efficacy studies typically need not be GLP. The FDA evaluates the distinction during submission review.

No. GLP applies to nonclinical safety studies (what happens in the lab before human trials). GMP applies to manufacturing of drug substances and products for clinical use and commercial distribution. Different quality systems, different regulations (21 CFR 58 vs. 21 CFR 210/211), different facilities.

FDA through the Bioresearch Monitoring (BIMO) program, which inspects GLP facilities. International GLP compliance is recognized through OECD Mutual Acceptance of Data (MAD) when the work is performed at a facility under a country with an OECD-recognized monitoring program.