OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring – OECD


 

GLP consensus documents  I  Guidance Documents for Compliance Monitoring Authorities  

Advisory Documents of the Working Group on GLP  I  Position Papers

 

Document listing

OECD Principles of GLP

No 1: OECD Principles on Good Laboratory Practice

 

GLP consensus documents

No 4: Quality Assurance and GLP (revised 1999)  (See also Frequently asked questions: FAQ)

 

No 5: Compliance of Laboratory Suppliers with GLP Principles(revised 1999)

 

No 6: The Application of the GLP Principles to Field Studies(revised 1999)

 

No 7: The Application of the GLP Principles to Short Term Studies (revised 1999)

 

No 8: The Role and Responsibilties of the Study Director in GLP Studies (revised 1999)

 

No 10: The Application of the Principles of GLP to Computerised Systems(1995)

[Note: this document has been replaced by Advisory Document No 17: Application of GLP Principles to Computerised Systems]

 

No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies

 

Guidance Documents for Compliance Monitoring Authorities

No 2: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice

No 3: Revised Guidance for the Conduct of Laboratory Inspections and Study Audit

No 9: Guidance for the Preparation of GLP Inspection Reports

 

Advisory Documents of the Working Group on GLP

No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP

No 12: Requesting and Carrying Out Inspections and Study Audits in Another Country

No 14: The Application of the Principles of GLP to in vitro Studies

No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP

No 16: Guidance on the GLP Requirements for Peer Review of Histopathology  

No 17: Application of GLP Principles to Computerised Systems

[Note: this document replaces Consensus Document No. 10: The Application of the Principles of GLP to Computerised Systems]

No. 19: Management, Characterisation and Use of Test Items

No. 22: GLP Data Integrity

 

Position Papers

No. 18: OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025

No. 21: OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
 

The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)

– ‘Outsourcing’ of Inspection Functions by Glp Compliance Monitoring Authorities (2006)

 

Guidance for Receiving Authorities 

No. 20: Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies

 

The PROGRAMME

CONTACT & SOCIAL MEDIA

 

Related Documents

 



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