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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 (No. 1-14), and are also available on the website "OECD's Work on Good Laboratory Practice".
Most OECD Documents are also available in German:
- Nr. 1 OECD-Grundsätze der Guten Laborpraxis (Neufassung aus dem Jahr 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 Qualitätssicherung und Gute Laborpraxis (überarbeitet 2001)
- Nr. 5 Einhaltung der GLP-Grundsätze durch Lieferanten (überarbeitet 2001)
- Nr. 6 Die Anwendung der GLP-Grundsätze auf Freilandprüfungen (überarbeitet 2001)
- Nr. 7 Die Anwendung der GLP-Grundsätze auf Kurzzeit-Prüfungen (überarbeitet 2001)
- Nr. 8 Die Rolle und Verantwortlichkeiten des Prüfleiters bei GLP-Prüfungen (überarbeitet 2001)
- 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
- 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)