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 procedures for continuous improvement outside of...

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 compliance of the test facility and of the...

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 this document need to understand the data...

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 presents possible scenarios in which the sponsor...

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 interpretation of the submitted data or the risk...

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, characterised, archived and disposed. The document...

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 intention of this document is to provide...

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 the two documents when applied within a GLP...

The peer review process can lead to changes in the interpretation of the slides and the reported results, and potentially the outcome and conclusions of the study. The purpose of this document is to provide guidance to pathologists, test facility management, study directors and quality assurance...

This document is a statement of policy set by the 1989 Council Decision-Recommendation on Compliance with Good Laboratory Practice [C(89)87(Final). It reiterates the decisions and the recommendations related to the role and responsibilities of governments, national GLP compliance monitoring...