Mark | Date Date | Title Title | |||
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No. 24 | 18 Jul 2022 |
Position Paper on Quality Improvement Tools and GLP
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported. The GLP Principles do not explicitly require... |
|||
No. 23 | 20 Sept 2021 |
Second edition: Quality Assurance and GLP
A Quality Assurance (QA) Programme is a cornerstone in the OECD Principles on Good Laboratory Practice (GLP) within a test facility. QA constitutes an internal mechanism of continuous monitoring for assuring test facility management (TFM) of the GLP... |
|||
No. 22 | 20 Sept 2021 |
GLP Data Integrity
This document provides guidance for test facilities or test sites that conduct GLP studies or GLP study phases. The guidance aims to promote a risk-based approach to the management of data that includes data risk, criticality and life cycle. Users of... |
|||
No. 21 | 07 May 2020 |
OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
The purpose of this document is to clarify the requirements of the GLP Principles regarding the relationship between test facilities and sponsors and the documentation test facilities are expected to maintain about those relations. This document... |
|||
No. 20 | 23 Jul 2019 |
Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies
The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and... |
|||
No. 19 | 19 Apr 2018 |
Management, Characterisation and Use of Test Items used in GLP studies
This guidance provides clarity for test facilities on the expectations of national Good Laboratory Practice (GLP) compliance monitoring authorities on how test items are transported, received, identified, labelled, sampled, handled, stored,... |
|||
No. 18 | 09 Feb 2016 |
OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
This document compares the OECD Principles of Good Laboratory Practice (OECD GLP) and ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories. It explainx what are, in general, philosophical differences between... |
|||
No. 17 | 11 Sept 2016 |
Application of GLP Principles to Computerised Systems
This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The... |
|||
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... |
|||
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... |
|||
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. |
|||
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. |
|||
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. |
|||
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. |
|||
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. |
|||
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. |
|||
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. |
|||
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. |
|||
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... |
|||
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. |
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
- Discontinued
This is the complete set of the series on OECD Principles of Good Laboratory Practice (GLP) which set the quality standards for the organisation and management of test facilities and for performing and reporting studies related to the safety of chemical substances and preparations. The GLP Principles cover all aspects of a laboratory’s daily activity, such as the layout of testing and storage areas to prevent contamination, cleaning and calibration of equipment, handling of test animals, and recording and archiving of test results. The GLP Principles thereby help ensure that studies submitted to regulatory authorities, to notify or register chemicals, are of sufficient quality and rigour and are verifiable.
English Also available in: French
- ISSN: 2077785X (online)
- https://doi.org/10.1787/2077785x
1 - 20 of 25 results
Position Paper on Quality Improvement Tools and GLP
OECD
18 Jul 2022
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which studies are planned, performed, monitored, recorded, archived and reported. The GLP Principles do not explicitly require...
Second edition: Quality Assurance and GLP
OECD
20 Sept 2021
A Quality Assurance (QA) Programme is a cornerstone in the OECD Principles on Good Laboratory Practice (GLP) within a test facility. QA constitutes an internal mechanism of continuous monitoring for assuring test facility management (TFM) of the GLP...
GLP Data Integrity
OECD
20 Sept 2021
This document provides guidance for test facilities or test sites that conduct GLP studies or GLP study phases. The guidance aims to promote a risk-based approach to the management of data that includes data risk, criticality and life cycle. Users of...
OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
OECD
07 May 2020
The purpose of this document is to clarify the requirements of the GLP Principles regarding the relationship between test facilities and sponsors and the documentation test facilities are expected to maintain about those relations. This document...
Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies
OECD
23 Jul 2019
The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and...
This guidance provides clarity for test facilities on the expectations of national Good Laboratory Practice (GLP) compliance monitoring authorities on how test items are transported, received, identified, labelled, sampled, handled, stored,...
OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025
OECD
09 Feb 2016
This document compares the OECD Principles of Good Laboratory Practice (OECD GLP) and ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories. It explainx what are, in general, philosophical differences between...
Application of GLP Principles to Computerised Systems
OECD
11 Sept 2016
This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The...
Guidance on the GLP Requirements for Peer Review of Histopathology
OECD
02 Jan 2015
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...
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP
OECD
11 Jun 2007
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...
The Application of the Principles of GLP to in vitro Studies
OECD
01 Dec 2004
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.
The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies
OECD
25 Feb 2002
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.
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.
The Role and Responsibility of the Sponsor in the Application of the Principles of GLP
OECD
22 Jan 1998
This document defines the role and responsibility of the sponsor in the application of the Principles of Good Laboratory Practice.
The Application of the Principles of GLP to Computerised Systems
OECD
05 Oct 1995
This document specifies the application of the Principles of Good Lab Practice regarding the use of computerised systems.
Guidance for the Preparation of GLP Inspection Reports
OECD
05 Oct 1995
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.
The Role and Responsibilities of the Study Director in GLP Studies
OECD
15 Sept 1999
This document defines the roles and responsibilities of the Study Director in Good Laboratory Practice studies.
The Application of the GLP Principles to Short Term Studies
OECD
13 Feb 2003
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.
The Application of the GLP Principles to Field Studies
OECD
15 Sept 1999
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...
Compliance of Laboratory Suppliers with GLP Principles
OECD
28 Sept 2000
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.