Last reviewed 4 October 2021
A new document has been published for test facilities or test sites that conduct good laboratory practice (GLP) studies or GLP study phases to promote a risk-based approach to the management of data that includes data risk, criticality and life cycle.
In 1981 the Organisation for Economic Cooperation and Development (OECD) formulated the principles of GLP, to ensure the quality and integrity of test data related to non-clinical safety studies so that analytical data generated in one member country could be accepted by another member country.
The European Community later accepted the principles of GLP, ratified as EC Directives, which resulted in the Good Laboratory Practice Regulations 1999 in the UK.
The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies. The new OECD Advisory Document on GLP Data Integrity provides guidance for test facilities or test sites that conduct GLP studies and aims to promote a risk-based approach to the management of data.
The document states that data integrity is the degree to which data are complete, consistent, accurate, trustworthy and that these characteristics of the data are maintained throughout the data life cycle. Data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded and accurate, whether raw data or a verified copy.