Histopathology Peer Review for Nonclinical Studies -- GLP Processes and Conditions

Natesan Settiagounder

Abstract


Conduct of nonclinical studies in compliance with Good Laboratory Practice (GLP) for safety assessment of products is mandated and monitored by multiple regulatory agencies globally. Histopathology examination of slides from any pivotal toxicology study is a critical phase performed by a study pathologist, who contributes substantially to the outcome and conclusions toward judging a product for further development, authorization or licensing. Considering such examination is scientific yet subjective based on study pathologist’s experience and expertise, the practice/expectation has been to subject at least a subset of slides for peer review by another pathologist, despite absence of regulatory need. Diverse practices and controversies around the peer review process, documentation, and reporting have continued for over three decades. The Organisation for Economic Co-operation and Development (OECD) guidance on GLP requirements for peer review of histopathology (OECD, 2014) provided a concise account; nevertheless, dissension persists [20]. The United States Food and Drug Administration's (FDA) Proposed Rule 2016 (21 CFR Part 58) brings GLP quality system framework, consistency with the OECD and the United States Environmental Protection Agency (EPA) requirements, and inclusion in the study protocol of procedures to be followed when a study includes peer review of any phase [1]. This paper goes critically between the lines of GLP definitions, expectations, processes and conditions focusing purely on GLP compliance to peer review process across stakeholders globally.

Keywords


regulatory affairs, nonclinical/preclinical safety assessment, toxicologic pathology, good laboratory practice/GLP, histopathology, pathology peer review, quality assurance

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References


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