Good Laboratory Practice (GLP) under 21 CFR Part 58 is FDA's rule for nonclinical laboratory studies that support applications for FDA-regulated products. This page is for laboratories that run, or plan to run, regulated nonclinical studies and need their GLP operating system built or corrected. Integral Healthcare Solutions (IHS) builds the document-control and quality-system procedures under your technical lead; your study directors and quality assurance unit own the science.

Last reviewed: October 2026.

What is GLP under 21 CFR Part 58?

The governing text is FDA's "Good Laboratory Practice for Nonclinical Laboratory Studies," 21 CFR Part 58, current eCFR text. Section 58.1(a) sets its reach: "This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products" (21 CFR 58.1(a)). The same section says compliance "is intended to assure the quality and integrity of the safety data filed" under the listed statutes.

FDA's bioresearch monitoring definitions describe GLP as "A quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported." A nonclinical laboratory study is "In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety," and the study director is "The individual responsible for the overall conduct of a nonclinical laboratory study" (FDA BIMO definitions).

Pesticide studies fall under EPA's counterpart, 40 CFR Part 160, which "prescribes good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA" (40 CFR 160.1(a)).

Who needs it and what triggers it

The buyer is a laboratory conducting nonclinical studies whose data will support an FDA application, or a laboratory moving into that work. The usual triggers:

• A study is planned that will "support or are intended to support applications for research or marketing permits" for an FDA-regulated product (58.1(a)).
• The laboratory has no independent quality assurance unit yet, or its QA staff also work on the studies they inspect, which section 58.35(a) addresses.
• SOPs are missing for subjects that section 58.81(b) requires, or deviations are not being authorized and recorded as section 58.81(a) requires.
• The laboratory is correcting a GLP operating system after an internal review or a sponsor audit.

How IHS helps

IHS runs a bounded organizational workstream under the laboratory's technical lead. The process:

1. A gap assessment of document control, QA unit independence, records, deviation handling and archives against 21 CFR Part 58.
2. A responsibility map across management, study directors and the QA unit, so each requirement has a named owner.
3. Drafting of the SOP framework, document-control, deviation and archive procedures, for your study directors and QA unit to review and approve.
4. A mock document audit of the assembled system against the regulation.
5. Drafted responses to the mock audit findings, and readiness support while your team closes them.

What you supply: your current SOPs, the study scope, an organization chart, your study directors and an independent QA unit.

The limit: study design, scientific validity, equipment validation and QA independence belong to the laboratory. IHS does not act as the QA unit or the study director. FDA inspections and sponsor audits are hosted by the laboratory, and the laboratory, not IHS, deals with FDA and sponsors.

What to have ready

Each item ties to 21 CFR Part 58 (current eCFR text, read October 2026) unless another source is named.

• A list of studies, marked for whether each supports or is intended to support an FDA application for research or marketing permits (58.1(a)).
• An organization chart showing a quality assurance unit "entirely separate from and independent of the personnel engaged in the direction and conduct of that study" (58.35(a)).
• A QA inspection schedule set at "intervals adequate to assure the integrity of the study" (58.35(b)).
• Study directors identified in your study records. FDA's BIMO definitions describe the study director as "The individual responsible for the overall conduct of a nonclinical laboratory study" (FDA BIMO definitions).
• A deviation procedure under which "All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data" (58.81(a)).
• SOPs for test and control article handling (58.81(b)).
• SOPs for data handling, storage and retrieval (58.81(b)).
• SOPs for equipment maintenance and calibration (58.81(b)).
• 58.81(b) lists twelve subjects (animal room preparation, animal care, test and control article receipt through sampling, test system observations, laboratory tests, handling of moribund or dead animals, necropsy, specimen collection and identification, histopathology, data handling storage and retrieval, equipment maintenance and calibration, animal transfer and identification), and states the list is "not limited to" them; 58.81(d) also requires a historical file of SOPs and revisions.
• For any pesticide studies, a map of which work falls under EPA's 40 CFR Part 160 instead (160.1(a)).

The introductory call is the place to go through this list against your laboratory's current documents.

How it compares

We did not review OECD GLP materials or laboratory competence accreditation programs for this page, so they are not summarized here.

What it costs

21 CFR Part 58 describes how studies are run; the pages we reviewed state no fee for GLP compliance. IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal or regulatory advice on whether a given study must follow Part 58.
• IHS does not serve as your QA unit or study director and does not judge scientific validity or validate equipment.
• IHS does not guarantee the outcome of an FDA inspection or a sponsor audit, and it does not deal with FDA on your behalf.

Frequently asked questions

What is GLP and which studies have to follow 21 CFR Part 58?

FDA describes GLP as "A quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported" (FDA). Part 58 covers "nonclinical laboratory studies that support or are intended to support applications for research or marketing permits" for FDA-regulated products, including human and animal drugs, medical devices for human use and biological products (58.1(a)).

Does my lab need GLP compliance for an IND or a 510(k) safety study?

Section 58.1(a) reaches studies that support "applications for research or marketing permits" for products including human drugs and medical devices for human use. Whether a particular study falls inside that scope is a regulatory determination for your sponsor and regulatory counsel; this page does not make it.

Is there a GLP certification for US labs, or is compliance shown by FDA inspection?

The sections of Part 58 cited on this page describe how studies are run and organized, not an application or certificate. IHS's reading (October 2026) is that FDA GLP compliance is shown through FDA inspection and sponsor audit rather than a certificate. Confirm this with your regulatory counsel before relying on it.

What does a GLP quality assurance unit do, and does it have to be independent?

Under 58.35(b) the QA unit inspects each study at "intervals adequate to assure the integrity of the study." It must be independent: section 58.35(a) requires it to be "entirely separate from and independent of the personnel engaged in the direction and conduct of that study" (eCFR).

Can a small lab use a contract QA unit to meet 21 CFR 58.35?

Section 58.35(a) sets the test: the QA unit must be "entirely separate from and independent of the personnel engaged in the direction and conduct of that study." Whether a contracted arrangement meets that test for your studies is a decision for laboratory management and regulatory counsel. IHS documents whichever structure you choose but does not serve as the QA unit.

What SOPs does 21 CFR 58.81 require?

Section 58.81(b) lists required SOP subjects, including test and control article handling, data handling, storage and retrieval, and equipment maintenance and calibration (eCFR). Read the full list in 58.81(b) when building your SOP index.

How should a GLP lab handle SOP deviations?

Section 58.81(a) is direct: "All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data." A deviation procedure should route each deviation to the study director and record it in the raw data.

FDA GLP vs EPA GLP vs OECD GLP: which applies to my studies?

FDA's 21 CFR Part 58 covers studies supporting applications for FDA-regulated products. EPA's 40 CFR Part 160 covers studies supporting applications for "pesticide products regulated by the EPA" (160.1(a)). We did not review OECD GLP materials for this page and do not summarize them here.