Abstract
The pathology peer review (PR) is an important part of the assessment process of key toxicological results and increases confidence in the quality of histopathology study data. On the other hand, in the last few years, on the basis of findings recorded in the Food and Drug Administration warning letters, a large debate on PR took place and several position papers were issued by either scientific association of pathologists and Quality Assurance (QA) associations. The Guidance on the GLP requirements for Peer Review of Histopathology was issued in May 2010 by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). This document gave an opportunity to the Italian Group of Quality Assurance in Research (the Italian acronym for which is GIQAR) to discuss more in depth this matter in an ad hoc Round Table. The decision to comment the above MHRA document in order to issue a GIQAR position paper was based on the lack of guidance regarding pathology PR and on the need for a thorough exchange of views among all involved parties as well as to provide recommendations to QA professionals on this specific issue.
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