Good clinical laboratory practice (GCLP) is a

GxP GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is ...

guideline for laboratory samples from clinical studies.

Good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...

(GCP) does not define requirements for laboratories and

good laboratory practice In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, ...

(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 The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...

and the British

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

issued their own versions of a GCLP guideline.

Literature

* WHO Good Clinical Laboratory Practice (GCLP) * 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. * Grant, Vanessa and Stiles, Tim, Research Quality Association (2003 and revised in 2012), Good Clinical Laboratory Practice

External links

WHO Good Clinical Laboratory Practice (GCLP) (11 Oct 2010)

MHRA guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples (11 Oct 2010)Research Quality Association (RQA)
Quality management Good practice {{pathology-stub