Good clinical laboratory practice
Good clinical laboratory practice is a GxP guideline for laboratory samples from clinical studies.
Good clinical practice does not define requirements for laboratories and good laboratory practice focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested in 2003 a guideline to close the gap. Later the World Health Organization and the British Medicines and Healthcare products Regulatory Agency issued their own versions of a GCLP guideline.
Literature
- WHO Good Clinical Laboratory Practice
- Stevens W. Good Clinical Laboratory Practice : The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
- Grant, Vanessa and Stiles, Tim, Research Quality Association, Good Clinical Laboratory Practice