International Journal of Education and Research in Health Sciences
(Official Publication of Sai Amrut Educational and Medical Research Foundation, Aurangabad)
 

Vol.1, Issue 4 (2018)



Good Clinical Laboratory Practice: Eminence Challenge in Clinical Laboratory

Sangita M Patil



Abstract

INTRODUCTION: In a clinical trial, good clinical laboratory practice (GCLP) is a standard system that provides guidance which applies in good laboratory practice (GLP) and good clini¬cal practice (GCP) ethics for the investigation of samples. GLP is one of the quality systems which overcomes the organizational process and different situations through it non-clinical laboratory studies are made, planned observed, verified, archived and reported. Quality and validity of non-clinical test data are planned and pro¬moted by GLP (OECD GLP Guideline). GCP is clinical trials which have to be planned, directed, watched, recorded, investigated and reported as per worldwide moral and precise quality that encom¬pass the involvement of human individuals. On behalf of agreement with this standard, it provides community guarantee. According to GCP, welfare or maintenance of trial subjects become secure and constant by various ethics which have on basis of Declaration of Helsinki. Considering combined guidelines of GLP and GCP, GCLP confirms the quality and reliability of the clinical trial data generated by laboratories. In 2003, the British Association of Research Quality Assurance (BARQA), first described Good Clinical Laboratory Practice guide¬lines, which were created to bridge the gap between guidelines for GCP and GLP. In other words, GCLP is one type of agenda through which organizations can do to develop systems and trials which give a guarantee of laboratory work and results.


Keywords

Good Clinical Laboratory Practice


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International Journal of Education and Research in Health Sciences






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