Good laboratory practice (GLP) for non-clinical laboratories means the OECD Principles of GLP, as revised in 1997, and in the United States the FDA's 21 CFR Part 58. Both apply to non-clinical safety studies submitted to regulators, and both require a study director, an independent quality assurance programme, approved study plans and archived raw data.
This guide is for managers of contract research organisations, in-house toxicology and analytical laboratories, and R&D quality teams.
Which studies need GLP?
GLP applies to non-clinical health and environmental safety studies that a regulator requires for registering or licensing a product. The OECD Principles name pharmaceuticals, pesticides, cosmetics, veterinary drugs, food and feed additives and industrial chemicals. Depending on the jurisdiction, other regulated products such as medical devices may be included.
OECD's GLP page gives examples: physical-chemical testing, toxicity and mutagenicity studies, environmental toxicity, residue studies, and analytical and clinical chemistry testing. Work can take place in the laboratory, in greenhouses or in the field. GLP does not cover studies that use human subjects.
The test is the destination of the data. OECD says GLP is not intended or required for non-regulated testing. Testing that will never be submitted to a regulator does not need GLP.
What do the OECD Principles and 21 CFR Part 58 require?
The OECD Principles were first published in 1981 as part of the Council Decision on the Mutual Acceptance of Data. The revised text was adopted by the OECD Council on 26 November 1997 and is No. 1 in OECD's GLP series. Section II sets out ten principles.
They cover test facility organisation and personnel, the quality assurance programme, facilities, apparatus and reagents, test systems, and test and reference items. They also cover standard operating procedures, performance of the study, reporting of results, and storage and retention of records and materials.
Two roles carry the system. The study director is the single point of control for each study. Quality assurance staff should not be involved in the conduct of the study they inspect.
21 CFR Part 58 covers studies that support applications to the FDA. It was first published on 22 December 1978. Its subparts run from general provisions to disqualification of testing facilities, with the study director in section 58.33 and the quality assurance unit in 58.35.
FDA proposed a revised rule on 24 August 2016, and no final rule had appeared in the Federal Register at the time of writing. The current text is on eCFR.
For electronic data, OECD has advisory documents on computerised systems (No. 17, 2016, with a 2023 supplement on cloud computing) and on GLP data integrity (No. 22, 2021).
How is GLP different from ISO/IEC 17025:2017?
OECD's position paper No. 18 (2016) compares the two. It concludes that they have different purposes and that applying one to meet the aims of the other is in many cases inappropriate. The table summarises the main differences.
| Point | OECD GLP | ISO/IEC 17025:2017 |
|---|---|---|
| Origin | Government regulatory control for safety data | Laboratory and accreditation community |
| Focus | Each study, run to a study plan and ending in one study report | The laboratory's ongoing competence and valid results |
| Key roles | Study director, quality assurance programme | Laboratory management, technical competence |
| Recognition | Inspection by a national GLP compliance monitoring authority | Accreditation by an accreditation body for a defined scope |
| International acceptance | Mutual Acceptance of Data among adhering countries | Arrangements between accreditation bodies, now under Global ACI (formerly ILAC and IAF) |
| Also expects | Archiving that lets a study be reconstructed | Internal quality control, proficiency testing, customer requirements |
ISO/IEC 17025:2017 is the current edition. iso.org shows it was last reviewed and confirmed in 2023. Our ISO/IEC 17025:2017 guide covers accreditation in detail.
How does a laboratory become GLP compliant?
Through a national GLP compliance monitoring programme, not an accreditation or certification body. The programme inspects test facilities and audits individual studies. A facility that passes periodic inspections is recognised as GLP compliant.
In most countries a facility applies to its national programme for inspection. In others, the programme can inspect any facility that claims to work to GLP. Under the Mutual Acceptance of Data, adhering countries accept GLP data from facilities inspected by a recognised national programme. Before you plan a study, check which authority will receive the data and whether it accepts studies from your country.
What records will a GLP inspector ask to see?
Inspectors want to reconstruct a study years later from the archive. These are the records most often traced. The list is AGS's practical reading of the Principles, not their wording.
- A master schedule of all studies at the facility, kept current.
- A study plan signed by the study director. The signature date is the study initiation date.
- Amendments and deviations kept apart. An amendment is an intended change to the plan, and a deviation is an unintended departure.
- Raw data recorded promptly, with every change traceable.
- Test item receipt, characterisation, storage and chain-of-custody records.
- Quality assurance inspection records and the QA statement in the final report.
- Training records, job descriptions and the SOPs in force at the time.
- An archive index showing where each study plan, raw data set, report and specimen is kept.
Where do ISO 15189 and ISO 9001 fit?
ISO 15189:2022 sets requirements for quality and competence in medical laboratories. It matters to a non-clinical lab only if the same organisation also examines human samples as a medical laboratory. Our ISO 15189 guide explains it.
ISO 9001:2026 was published in September 2026, and iso.org lists ISO 9001:2015 as withdrawn. A quality management certificate can suit a research organisation as a whole, but it does not replace GLP compliance or ISO/IEC 17025 accreditation.
How AGS can help
The IMS Non-Clinical R&D Laboratories kit contains 87 editable Microsoft Word documents. They include a quality manual and policies, 25 procedures such as GLP study conduct, the QA programme, data integrity and archiving, 35 forms including a GLP study plan and QAU inspection report, and 8 checklists. The documents cite the 1997 OECD Principles, 21 CFR Part 58, ISO/IEC 17025:2017, ISO 15189:2022 and ISO 9001:2015, so review them against ISO 9001:2026.
Frequently asked questions
Is GLP a certification?
No. GLP compliance is confirmed by inspection under a national compliance monitoring programme. Certification bodies certify management systems, and accreditation bodies accredit laboratories against ISO/IEC 17025.
Can an ISO/IEC 17025 accredited lab run GLP studies?
Only if it also meets the GLP Principles and is inspected under GLP. OECD notes that accreditation is not applied to non-clinical safety testing because ISO/IEC 17025 does not contain all GLP requirements.
Has 21 CFR Part 58 been replaced?
No. FDA proposed a revised rule in August 2016, but the current eCFR text is still the one in force.
Does documentation make a lab GLP compliant?
No. Documents describe the system. Compliance depends on how studies are run and on what the inspectors find.
AGS provides independent documentation toolkits. This guide and the referenced kit are not affiliated with, endorsed by or approved by the OECD, the US FDA, ISO or any GLP compliance monitoring authority. They do not guarantee any inspection, accreditation or certification outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
