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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... |
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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... |
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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... |
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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... |
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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... |
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
- Discontinué
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.
Egalement disponible en : Français
- ISSN : 2077785X (en ligne)
- https://doi.org/10.1787/2077785x