Refining the methodology for verifying GLP studies submitted within an application for regulated products

Abstract

OECD Good Laboratory Practice (GLP) principles were developed by governments as a regulatory control mechanism to ensure that safety studies would be of acceptable quality and integrity. EU Directives 2004/09/EC and 2004/10/EC incorporate the OECD GLP principles into the EU regulatory framework, requiring that studies submitted for the assessment and authorization adhere to the principles of GLP. In its role as European risk assessor authority, EFSA launched a project to strengthen the methodology for verifying GLP studies for all regulated product areas under its remit, with three main objectives: to establish verification methodology and tools through a fit for purpose GLP verification checklist, to test the methodology by applying it to substantial amount of studies across different regulatory areas and different study types and to develop a hands-on training program for GLP assessors and scientific units/risk assessors for the use and understanding of the created GLP checklist. Following these objectives, the study evaluation had two levels of assessment: identification of GLP observations and assessing scientific reliability of studies where GLP observations were made. Around 1,000 studies were investigated to examine the developed methodology. The GLP verification checklist proved to be fit for purpose for verifying GLP studies. Hands-on training was made available on the EU academy platform (https://academy.europa.eu/).