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.
Nonclinical health and environmental safety studies conducted in OECD member and adhering countries. The basis for national GLP compliance-monitoring programmes worldwide.
- 01Test facility organisation with a designated study director per study
- 02An independent quality assurance programme
- 03SOPs for all routine facility operations
- 04Retention and archiving of records, raw data, and specimens
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.
OECD GLP Principles: frequently asked questions
Quick answers to common questions about OECD GLP Principles.
What is OECD GLP Principles?
OECD GLP Principles — OECD Principles of Good Laboratory Practice — is a standard issued by the Organisation for Economic Co-operation and Development. 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.
Who does OECD GLP Principles apply to?
Nonclinical health and environmental safety studies conducted in OECD member and adhering countries. The basis for national GLP compliance-monitoring programmes worldwide.
What are the key requirements of OECD GLP Principles?
OECD GLP Principles requires, among other things: 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.
When was OECD GLP Principles last updated?
The current version of OECD GLP Principles dates from January 1998. 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.
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When OECD GLP Principles — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.