Good Clinical Laboratory Practice
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Good Clinical Laboratory Practice (GCLP) is a GxP Guideline for laboratory samples from clinical studies.
GCP does not define requirements for laboratories and GLP focusses on pre-clinical analyses and not on human samples from clinical trials. Therefore the British Association of Research Quality Assurance (BARQA) suggested in 2003 a Guideline to close the gap. Later the WHO and the British Health Authority MHRA issued their own versions of a GCLP Guideline.
- 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.
- WHO Good Clinical Laboratory Practice (GCLP) (as of 11OCT2010)
- MHRA Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples (as of 11OCT2010)
- BARQA GCLP, A Quality System for Laboratories that undertake the Analyses of Samples from Clinical Trials (as of 11OCT2010)
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