title: Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology.
abstract: In 2014, the Organisation for Economic Co-operation and Development (OECD) issued guidance no. 16, Guidance on the GLP Requirements for Peer Review of Histopathology. The stated purpose of the guidance document is "to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented, and reported in order to meet Good Laboratory Practice (GLP) expectations and requirements." On behalf of and in collaboration with the global societies of toxicologic pathology, the Society of Toxicologic Pathology initiated a review of OECD guidance no. 16. The objectives of this review are to provide a unified interpretation of the guidance, to recommend compliant processes for organizations to implement, and to avoid inconsistent process adaptations across the industry. This review of the guidance document is the product of a global collaboration with other societies of toxicologic pathology and provides a section-by-section international consensus view and interpretation of the OECD guidance on peer review.
authors.affiliation: Biogen, Cambridge, Massachusetts, USA Both James D. Fikes and Daniel J. Patrick contributed equally to this article. jim.fikes@biogen.com.
authors.forename: James D
authors.initials: JD
authors.lastname: Fikes
authors.affiliation: MPI Research, Mattawan, Michigan, USA Both James D. Fikes and Daniel J. Patrick contributed equally to this article.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Patrick
authors.affiliation: US Food and Drug Administration, College Park, Maryland, USA.
authors.forename: Sabine
authors.initials: S
authors.lastname: Francke
authors.affiliation: GlaxoSmithKline, King of Prussia, Pennsylvania, USA.
authors.forename: Kendall S
authors.initials: KS
authors.lastname: Frazier
authors.affiliation: Amgen Inc., Seattle, Washington, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Reindel
authors.affiliation: Covance Laboratories, Porcheville, France.
authors.forename: Annette
authors.initials: A
authors.lastname: Romeike
authors.affiliation: RSPathologics, Granby, Colorado, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Spaet
authors.affiliation: Pfizer Inc., Andover, Massachusetts, USA.
authors.forename: Lindsay
authors.initials: L
authors.lastname: Tomlinson
authors.affiliation: Vet Path Services, Inc., Mason, Ohio, USA.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Schafer
mesh_terms: D000818:Animals; D006801:Humans; D066150:Organisation for Economic Co-Operation and Development; D010338:Pathology, Clinical / Q000592:standards*; D010380:Peer Review / Q000592:standards*; D014116:Toxicology / Q000592:standards*
keywords: GLP; OECD; guidance; histopathology; pathology; peer review; regulatory