Good Clinical Laboratory Practices (GCLP) are essential for ensuring the quality, integrity, and reliability of data derived from human clinical trials. With the increasing use of contract research organizations (CROs) for clinical trial sample analysis, the CRO and sponsor laboratories must understand the requirements of Good Clinical Practice (GCP) as well as Good Laboratory Practice (GLP). While GCP emphasizes ethics, safety, and quality aspects of the trial, the GLP focuses on sample and results integrity. GCLP guidelines were established to integrate the quality principles of GLP with the relevant elements of GCP.
The application of GCLP is the best practice to ensure the quality, integrity, and reliability of human clinical trial analysis data that these laboratories provide. The development of GCLP encompasses standards from 21 CFR Part 58 (GLP), 42 CFR Part 493 (CLIA), College of American Pathologist (CAP), International Conference on Harmonization (ICH), World Health Organization (WHO) and International Organization for Standardization (ISO) 15189.
Our consultants at Pace® Life Sciences are experienced in understanding how GCLP practices apply to your program and partner organizations, which enables us to provide an overview to help you understand how to navigate the intersection of these practices.
This white paper outlines the core elements of GCLP, detailing the necessary quality management systems, operational procedures, and compliance measures required to uphold high standards in clinical laboratory settings.
Donna Aliyetti | Senior Consultant - Quality Systems/Quality Assurance
Donna is an accomplished quality professional with extensive experience in the regulated biopharmaceutical industry. She has a passion for mentoring laboratories and organizations to develop and implement robust quality programs and processes for clinical research and bioanalysis. Her expertise is used to identify and lead initiatives to find solutions to quality challenges in a dynamic and rapidly expanding regulated GLP/GCLP compliant environment.
Edited by Christine Quigley | Senior Consultant - Quality Assurance/Compliance