OECD Principles of Good Laboratory Practice
The internationally harmonised GLP principles (OECD Series on Principles of GLP and Compliance Monitoring, No. 1) that underpin the Mutual Acceptance of Data (MAD) system — nonclinical safety data generated under GLP in one OECD member country is accepted by regulators in others, avoiding duplicative testing.
What this does not cover
stated in the document's own scope- Cover nonclinical health and environmental safety studies, not clinical studies in humans, which are governed by Good Clinical Practice (ICH E6).
- Set the quality system for study conduct, not the scientific test methods, which are the subject of the OECD Test Guidelines.
- Are an international instrument giving effect to MAD; domestic legal force comes from the national implementation, such as 21 CFR Part 58.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The OECD Principles of Good Laboratory Practice are the internationally harmonised quality-system principles for the conduct of nonclinical health and environmental safety studies. Published as No. 1 in the OECD Series on Principles of GLP and Compliance Monitoring, they define how such studies should be planned, performed, monitored, recorded, archived, and reported so that the resulting data are reliable and reconstructable. They set out the roles of the study director and the quality assurance programme, the requirements for facilities, apparatus, test-system and test-item control, standard operating procedures, and archives — the same architecture national GLP regulations are built on.
Scope & applicability
Nonclinical health and environmental safety studies conducted in OECD member and adhering countries. The basis for national GLP compliance-monitoring programmes worldwide.
Legal basis & how it acquires force
The OECD GLP Principles are issued as an OECD Council instrument; they are not directly binding on companies but bind adhering member countries to implement them and to operate a national GLP compliance-monitoring programme. Their central legal effect is the Mutual Acceptance of Data (MAD): nonclinical safety data generated in accordance with GLP and the OECD test guidelines in one adhering country must be accepted for assessment purposes by regulators in the others, which avoids duplicative testing. National implementations — such as 21 CFR Part 58 in the US — give the principles domestic legal force.
Document structure
| Part | Covers |
|---|---|
| Test facility organisation and personnel | Management responsibilities, the study director, and personnel duties |
| Quality assurance programme | The independent QA function and its inspection of studies, facilities, and processes |
| Facilities, apparatus, and materials | Facility design, equipment, and control of reagents and materials |
| Test systems and test/reference items | Care of biological and physical/chemical test systems and characterisation of test and reference items |
| Standard operating procedures and study conduct | SOPs, the study plan, and performance of the study |
| Reporting and archiving | The final report, and retention and archiving of records and materials |
Key requirements
- Test facility organisation with a designated study director per study
- An independent quality assurance programme
- SOPs for all routine facility operations
- Retention and archiving of records, raw data, and specimens
Implementation tips
- Map OECD roles to your Part 58 roles when running studies for both US and non-US submissions
- Confirm your national GLP monitoring authority membership to rely on MAD for a given market
Revision notes
The consolidated No. 1 principles (1997, ENV/MC/CHEM(98)17) remain the reference, supplemented by advisory and consensus documents in the OECD GLP series.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The OECD GLP Principles are the international reference that national GLP regulations implement — 21 CFR Part 58 (FDA) and 40 CFR 160/792 (EPA) in the US, and equivalent EU and Japanese regimes — so a study compliant with one is broadly recognised across OECD adhering countries under MAD. They pair with the OECD Test Guidelines, which specify the scientific methods, while the GLP Principles govern the quality system under which those methods are run.
OECD GLP Principles: frequently asked questions
Quick answers to common questions about OECD GLP Principles.
What is the Mutual Acceptance of Data (MAD)?
MAD is the OECD system under which nonclinical safety data generated to GLP and the OECD Test Guidelines in one adhering country must be accepted by regulators in the others for assessment, avoiding duplicative testing.
How do the OECD GLP Principles relate to 21 CFR Part 58?
The OECD Principles are the international harmonised standard; 21 CFR Part 58 is the US national implementation of GLP. They are closely aligned, which is what allows GLP studies to be mutually recognised across OECD countries.
Where are the OECD GLP Principles published?
As Number 1 in the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, issued as an OECD Council instrument.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.