Wytyczne i dokumenty OECD związane z DPL
Guidance Documents for Compliance Monitoring Authorities
Guidance Documents for Compliance Monitoring Authorities
- 2. Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice.
- 3. Revised Guidance for the Conduct of Laboratory Inspections and Study Audit.
- 9. Guidance for the Preparation of GLP Inspection Reports.
Consensus Documents
- 4. Quality Assurance and GLP.
- 5. Compliance of Laboratory Suppliers with GLP Principles.
- 6. The Application of the GLP Principles to Field Studies.
- 7. The Application of the GLP Principles to Short&Term Studies.
- 8. The Role and Responsibilities of the Study Director in GLP Studies
- 10. The Application of the Principles of GLP to Computerised Systems (This document is replace by Consensus Document No. 17: Application of GLP Principles to Computerised Systems)
- 13. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies.
Advisory Documents of the Working Group on GLP
- 11. The Role and Responsibility of the Sponsor in the Application of the Principles of GLP.
- 12. Requesting and Carrying Out Inspections and Study Audits in Another Country.
- 14. The Application of the Principles of GLP to in vitro Studies.
- 15. Establishment and Control of Archives that Operate in Compliance with the Principles of GLP.
- 16. Guidance on the GLP Requirements for Peer Review of Histopathology
- 17. Application of GLP Principles to Computerised Systems (This document replaces Consensus Document No. 10: The Application of the Principles of GLP to Computerised Systems)
- 19: Management, Characterisation and Use of Test Items
Position papers
- The use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994),
- “Outsourcing” of Inspection Functions by GLP Compliance Monitoring Authorities (2006).
- 18 : OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
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No. 21: OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
(NEW)
Guidance for Receiving Authorities (NEW)No. 20: Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies
