Organisation for Economic Co-operation and Development
Author of the OECD Principles of Good Laboratory Practice adopted across member countries.
WHAT OECD COVERS
The Organisation for Economic Co-operation and Development developed and maintains the Principles of Good Laboratory Practice, the international framework governing the conduct of non-clinical health and environmental safety studies.
WHERE IT SITS INTERNATIONALLY
The OECD GLP framework and FDA’s 21 CFR Part 58 are the two reference regimes, closely aligned in substance, with MAD providing the international acceptance mechanism.
HOW ITS REQUIREMENTS BITE
OECD does not inspect. Compliance is monitored by national GLP monitoring authorities in member and adhering countries, which inspect test facilities and audit studies. The framework’s real force comes from the Mutual Acceptance of Data system: data generated in one adhering country under GLP must be accepted by regulators in the others, which removes the need to repeat safety studies country by country.
WHAT OECD PUBLISHES
- 01OECD Principles of Good Laboratory Practice (as revised)
- 02OECD Series on Principles of GLP and Compliance Monitoring — the advisory documents
- 03OECD Test Guidelines for chemical and toxicological testing
- 04Guidance on GLP application to specific study types, including in-vitro and computerised systems
- 05Consensus documents on compliance monitoring procedures
WHAT PRACTITIONERS GET WRONG
- ›Mutual Acceptance of Data is the point of GLP — it is what makes a study accepted internationally without repetition.
- ›GLP applies to non-clinical safety studies, not to clinical trials or routine QC testing.
- ›The OECD advisory documents carry much of the practical interpretation, not just the Principles.
- ›FDA’s 21 CFR Part 58 and the OECD Principles are aligned in intent but differ in points of detail.
OECD STANDARDS SPEQ DECODES · 1
DISCIPLINES IN OECD’S REMIT
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