Development of new biomedical products necessitates nonclinical safety assessment in animals as a means of assessing potential risk to human patients. Pivotal nonclinical safety studies that support human clinical trials are performed according to Good Laboratory Practice (GLP) guidelines, which are designed to ensure that the study was conducted under carefully controlled conditions using standardized and validated procedures that will yield a reliable, reproducible, and traceable data set. The GLP guidelines established by different regulatory agencies address organizational structure, personnel responsibilities, personnel training practices, quality assurance (ensuring compliance), facilities, equipment, standard operating procedures, study documentation (record keeping), and record and sample retention. Academic institutions engaging in nonclinical safety assessment on-site have multiple options for implementing a GLP quality system. This article outlines the rationale supporting the use of a GLP-compliant or GLP-like quality system in academia and reviews key concepts needed to efficiently and effectively implement GLP in the academic setting. Emphasis is given to provision of GLP-compliant pathology support as (1) pathology data are an essential component of GLP nonclinical safety testing, (2) familiarity with pathology-related GLP procedures typically is gained first outside the academic setting, and (3) microscopic pathology diagnoses and interpretations require special accommodations to ensure that they are undertaken in a GLP-compliant fashion.
Keywords: GLP; good laboratory practice; nonclinical safety assessment; pathology; quality; regulatory filing.
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