A Roadmap for Academic Health Centers to Establish Good Laboratory Practice–Compliant Infrastructure

Abstract

Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.

Establishing molecular microbiology facilities in developing countries

“…All of the surface areas should be cleaned before and after usage. Working stations, tables, refrigerators and reagent containers should be regularly swabbed with 70% ethyl alcohol [37]. The use of disinfectants recommended by the environmental protection agency should be promoted.…”

Costs of Implementing Quality in Research Practice

“…However, compliance challenges can be lessened when executive administrators value quality and can offer support to address these needs. These unique GLP challenges and options for supporting a GLP program are discussed further in the literature (Hancock 2002;Adamo et al 2012Adamo et al , 2014. Understandably, studies that require GLP compliance do not present substantial flexibility in quality management components.…”

Using Current Data to Define New Approach in Age Related Macular Degeneration: Need to Accelerate Translational Research

“…The GLP compliance, including the stringent documentation requirements for personnel training, periodic study monitoring and quality assurance of data and resources is the hallmark of universal acceptance of data critical for translation [77, 78]. The data from various scientific reports is expected to have variations in results due to use of different methods and procedures of experiments and different techniques to conduct a given experiment.…”