The GCLPs are an international quality system for laboratories which undertake the analysis of samples from clinical trials using Good Laboratory Practice standards while assuring Good Clinical Practice standards are met.

While there is no individual regulation that mandates and describes the GCLPs, there are several widely acknowledged industry guidelines that describe and assist with the implementation of the GCLPs. The intent of these guidelines is to ensure that “that sample collection, analysis and reporting is performed to a standard which will ensure that patient safety is not compromised and that data is reliable, accurate and in compliance with GCP regulations.”