From Risk to Regulation: Ensuring GLP Compliance Through Risk Assessments for Nonclinical Laboratory Studies

This Capstone project completed risk assessments for Charles River Laboratories to support Good Laboratory Practice (GLP) regulations from the Food and Drug Administration, Organisation for Economic Co-operation and Development (OECD), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The risk assessments were used to identify the frequency of facility-based inspections for each department. Facility-based inspections are a GLP requirement of OECD, which assess compliance of areas that may not be covered in study-based inspections, including equipment maintenance and calibration, training documentation, or computerized systems. Upon completion of this project, CRL was able to support a 1-,2-,or 3-year facility-based inspection schedule for each department.