From Risk to Regulation: Ensuring GLP Compliance Through Risk Assessments for Nonclinical Laboratory Studies
Program: Applied Biotechnology Master's Degree — Quality Assurance and Compliance
Host Company: Charles River Laboratories
Location: Not Specified (remote)
Student: Nicole Brooks
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.