Last fall the membership was notified by email of an STP Scientific and Regulatory Policy Committee (SRPC) Working Group formed as an ad hoc response to regulatory guidance on pathology peer review. This Working Group continues to monitor and respond to emerging guidance and publications on histopathology peer review.
In 2017, the Journal of Regulatory Science published two articles on histopathology peer review that were considered by the SRPC Working Group to be inaccurate interpretations of U.S. regulation (21 CFR part 58) and international guidance (OECD No. 16). The SRPC Working Group responded to the articles with a letter to the editor in the Journal of Regulatory Science, to clarify STP’s interpretation of the GLP process as applied to pathology peer review. There was a subsequent reply to our letter.
The SRPC Working Group is notifying the STP membership since some of our Quality Assurance (QA) colleagues may have questions about these articles and the process of histopathology peer review. Hopefully, the SRPC Working Group’s letter to the editor may serve as a useful reference for you to engage in discussion with your QA colleagues.
The SRPC Working Group on Pathology Peer Review
Bindu Bennet & Frank Geoly (Co-Chairs), Karyn Colman, Jim Fikes, Sabine Francke, Natalie Keirstead, Karen Regan, Annette Romeike, Ken Schafer, Frederic Schorsch, Heath Thomas, Michael Thibodeau, John Vahle.