Good Clinical Laboratory Practice
Encyclopedia
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.
GxP
GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries....
Guideline for laboratory samples from clinical studies.
GCP
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
does not define requirements for laboratories and GLP
Good Laboratory Practice
In the experimental research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical ...
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
Who
Who may refer to:* Who , an English-language pronoun* who , a Unix command* Who?, one of the Five Ws in journalism- Art and entertainment :* Who? , a 1958 novel by Algis Budrys...
and the British Health Authority MHRA
MHRA
MHRA is an initialism that can stand for:*Malta Hotels and Restaurants Association*Medicines and Healthcare products Regulatory Agency*Michigan Hot Rod Association*Modern Humanities Research Association** MHRA Style Guide...
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.
External links
- 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)