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 compliance of the test facility and of the studies conducted therein. This document clarifies the requirements as stated in the GLP Principles and integrates a risk-based approach to manage GLP QA programmes It has also incorporates all QA aspects from past documents, updating and replacing Document No. 4.