Histopathology Evaluation and Peer Review for Nonclinical Studies: Raw Data Compliance to GLP Quality Systems

Natesan Settiagounder

Abstract


Histopathology evaluation of animal tissues from a nonclinical toxicological study by a study pathologist contributes substantially to the endpoint(s) of a GLP compliant study. Often, selected tissue slides, existing and new, evaluated by a study pathologist, are peer reviewed by an expert pathologist, to assure and improve quality of observations and interpretation. The peer review process, having scope to change certain components of a pathology report, can lead to changes in observations, interpretation and potential outcome/conclusions of a study. The GLP regulations of several countries provide quality system approaches, which are though similar have differences in their statutes and expectations. The heart of the matter of GLP quality systems is raw data to ensure their true reflection in final report and help reconstruction. In 1987, the U. S. FDA specially interpreted "raw data" applicable for histopathology evaluation. However, there is no conclusive change by other Agencies, except the OECD (2014) guidance. Inconsistencies and controversies prevailed during the last three decades on different perspectives of raw data applicable for histopathology evaluation and peer review of different types. This paper goes critically between the lines of GLP definitions, expectations and diverse practices, seeking harmonized interpretation by all stakeholders for complying with multiple regulations.

Keywords


raw data, quality system, good laboratory practice, histopathology, pathology peer review, nonclinical study

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References


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