Navigation und Service

OECD Documents on Good Laboratory Practice

The OECD Documents are published in the OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring, and are also available on the website "OECD's Work on Good Laboratory Practice" (https://www.oecd.org/).

Most OECD Documents are also available in German:

• Nr. 1 OECD Principles on Good Laboratory Practice (as revised in 1997)
• Nr. 2 Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995; corresponds to Annex A der Richtlinie 2004/9/EG vom 11. Februar 2004)
• Nr. 3 Revised Guidance for the Conduct of Laboratory Inspections and Study Audit (1995; corresponds to Annex B der Richtlinie 2004/9/EG vom 11. Februar 2004)
• Nr. 4 Quality Assurance and GLP (revised in 2001)
• Nr. 5 Compliance of Laboratory Suppliers with GLP Principles (revised in 1999)
• Nr. 6 The Application of the GLP Principles to Field Studies (revised in 1999)
• Nr. 7 The Application of the GLP Principles to Short Term Studies (revised in 1999)
• Nr. 8 The Role and Responsibilities of the Study Director in GLP Studies (revised in 1999)
• Nr. 9 Guidance for the Preparation of GLP Inspection Reports (1995; no German translation available)
• Nr. 10 The Application of the Principles of GLP to computerised Systems (1995)
• Nr. 11 The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP (1998; no German translation available)
• Nr. 12 Requesting and Carrying out Inspections and Study Audits in another Country (2000; no German translation available)
• Nr. 13 The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002)
• Nr. 14 The Application of the Principles of GLP to in vitro Studies (2004)
• Nr. 15 Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
• Nr. 16 Guidance on the GLP Requirements for Peer Review of Histopathology
• Nr. 17 Application of GLP Principles to Computerised Systems (updated 2022)
• Nr. 18 OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 (2016)
• Nr. 19 Document of the Working Group on Good Laboratory Practice on the Management, Characterisation and Use of Test Items (2018)
• Nr. 20 Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies (2019)
• Nr. 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies (2020)
• Nr. 22 OECD Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity
• Nr. 23 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP
• Nr. 24 Position Paper on Quality Improvement Tools and GLP

Up