17 results
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No. 16 | 02 Jan 2015 |
Guidance on the GLP Requirements for Peer Review of Histopathology
This document provides guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented and reported in order to meet GLP expectations... |
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No. 15 | 11 Jun 2007 |
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
This document provides guidance concerning the establishment and control of archives compliant with the principles of Good Laboratory Practice, and is intended for use by test facilities, contract archives and quality assurance units and comliance... |
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No. 14 | 01 Dec 2004 |
The Application of the Principles of GLP to in vitro Studies
This document facilitates the proper application and interpretation of the GLP Principles for the organisation and management of in vitro studies, and provides guidance for the appropriate application of the GLP Principles to in vitro studies. |
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No. 13 | 25 Feb 2002 |
The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies
This document provides guidance on the issues that are involved in the planning, performance, monitoring, recording, reporting and archiving of multi-site non-clinical health and environmental safety studies. |
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No. 12 | 25 Jun 2002 |
Requesting and Carrying out Inspections and Study Audits in another country
This document sets out recommended procedures to use when requesting and carrying out inspections and study audits in another country under the Principles of Good Lab Practice and Compliance Monitoring. |
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No. 11 | 22 Jan 1998 |
The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
This document defines the role and responsibility of the sponsor in the application of the Principles of Good Laboratory Practice. |
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No. 10 | 05 Oct 1995 |
The Application of the Principles of GLP to Computerised Systems
This document specifies the application of the Principles of Good Lab Practice regarding the use of computerised systems. |
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No. 9 | 05 Oct 1995 |
Guidance for the Preparation of GLP Inspection Reports
This document suggests elements and/or concepts that can contribute to a useful report of a Good Laboratory Practice inspection and study audit. It may be used by Member countries as a component of their compliance monitoring programme. |
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No. 8 | 15 Sept 1999 |
The Role and Responsibilities of the Study Director in GLP Studies
This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies. |
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No. 7 | 13 Feb 2003 |
The Application of the GLP Principles to Short Term Studies
This document cites the appropriate OECD Principles of GLP and gives guidance on their interpretation in relation to short-term studies in a series of notes. |
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No. 6 | 15 Sept 1999 |
The Application of the GLP Principles to Field Studies
This document specifies the application of the Good Laboratory Practice principles to field studies, interpreting such concepts as study, test site, study director, management responsibilities, quality assurance, etc. for application in this specific... |
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No. 5 | 28 Sept 2000 |
Compliance of Laboratory Suppliers with GLP Principles
This document offers advice to both test facility management and suppliers as to how they might meet GLP requirements through national accreditation schemes and/or working to formal national or international standards, or by adopting other measures. |
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No. 4 | 26 Oct 1999 |
Quality Assurance and GLP
This document defines quality assurance programmes required to meet Good Laboratory Practice princples. |
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No. 3 | 14 Jun 1995 |
Revised Guidance for the Conduct of Laboratory Inspections and Study Audits
This document provides guidance for the conduct of laboratory inspections and study audit under the Principles of Good Laboratory Practice. |
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No. 2 | 14 Jun 1995 |
Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice
This document provides detailed practical guidance to OECD Member countries on the structure, mechanisms and procedures they should adopt when establishing national Good Laboratory Practice compliance monitoring programmes. |
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No. 1 | 26 Jan 1998 |
OECD Principles on Good Laboratory Practice
This document provides the full text of the OECD Principles of Good Laboratory Practice as revised in 1997. These principles cover the organisational process and the conditions under which laboratory studies are planned, performed, monitored,... |
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03 Sept 2014 |
‘Outsourcing' of Inspection Functions by Glp Compliance Monitoring Authorities
This document reiterates the decisions and the recommendations related to the role and responsibilities of governments, national GLP compliance monitoring authorities and inspectors with regard to outsourcing. |