GCLP stands for Good Clinical Laboratory Practice and defines quality standards intended for laboratory samples from clinical studies. It combines principles of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and thereby ensures the quality and reliability of the clinical trial data generated by laboratories. In contrast to GCLP, GCP does not define requirements for laboratories and GLP focusses on pre-clinical analyses and not on human samples from clinical trials.
The principles of GCLP are defined in the following guidance documents:
– Good Clinical Laboratory Practice of the World Health Organization (WHO) on behalf of the Special Programme for Research and Training in Tropical Diseases, 2009
– Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010) adopted by GCP Inspectors Working Group on 28 February 2012.