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经济合作与发展组织(OECD)GLP准则

OECD Principles of GLP

· 法规动态

The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

OECD Principles of GLP

No 1: OECD Principles on Good Laboratory Practice

GLP consensus documents

No 4: Quality Assurance and GLP (revised 1999)

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)

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

Position Papers

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

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

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

参考文献:

1.http://www.oecd.org/env/ehs/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm

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