Good clinical laboratory practice

Updated on Jan 07, 2024

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Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies.

Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) 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 (GCLP) ISBN 978-92-4-159785-2

Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): 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.

References

Good clinical laboratory practice Wikipedia

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