Corrigendum to Toxicologic Pathology Forum: Opinion on Performing Good Laboratory Practice Histopathology Evaluation for Nonclinical Toxicity Studies in a Remote Location

Hukkanen RR, Trapani M, Derringer T, et al. Toxicologic Pathology Forum: Opinion on Performing Good Laboratory Practice Histopathology Evaluation for Nonclinical Toxicity Studies in a Remote Location. Toxicologic Pathology. 2023;51(3):148-152. doi:10.1177/01926233231168133

The authors wish to correct the key learnings on national regulations applicable to the pathology phase of GLP studies within the UK, France, and other countries. Accordingly, the corrected paragraphs should read:

UK

The UK GLP Monitoring Authority (UK GLPMA), part of the Medicines and Healthcare products Regulatory Agency (MHRA) enforces GLP requirements in-line with the OECD Principles. The UK GLP Compliance Monitoring Program will inspect TF/TS on a risk-based interval, approximately every 2-3 years, and issue a statement of GLP compliance. Within the UK if a TF pathologist is geographically remote from the TF, the MHRA interprets the remote worksite to be an extension of the TF, subject to periodic TF QAU monitoring and assessment in line with OECD advisory document 23 at the remote worksite¹¹. If the study pathologist is geographically and organizationally distinct from the TF, their premises could be considered a TS of a multi-site study, in line with OECD consensus document 13 for multisite studies¹². In this case, the SP would be required to join the UK GLP compliance program and be subject to UK GLPMA inspections (additional information on this process can be obtained from the MHRA GLP website). In addition to the SP’s CV and JD, mandatory annual continuing education (CE) to maintain licensure as a veterinarian is required in the UK. Additional hours of annual CE are needed to maintain specialist qualification as a pathologist. Records of CE are included in the SP GLP training files.

France and Other Countries

National GLP requirements are enforced by the Agence nationale de sécurité du médicament et des produits de santé in France, the Federal Office for the Environment (FOEN) and Swiss Medic in Switzerland, the Italian Ministry of Health in Italy, the Irish National Accreditation Board in Ireland and the Israel Laboratory Accreditation Authority in Israel. The authors are not aware of notable differences between OECD Principles and the national regulations of these countries.

Two supplementary references have also been added to the references list:

11. The Organisation for Economic Co-operation and Development. OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE AND MONITORING; Number 23. Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP. November 4, 2022 (Cancels and replaces the same document of 18 July 2022). Accessed January 2, 2024. https://mobil.bfr.bund.de/cm/349/nr-23-oecd-advisory-document-of-the-working-party-on-good-laboratory-practice-on-quality-assurance-and-glp.pdf

12. The Organisation for Economic Co-operation and Development. OECD (2002), The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 13, OECD Publishing, Paris. Accessed January 2, 2024. https://doi.org/10.1787/9789264078772-en.

The online version of this article has been updated.