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DOI: 10.1055/s-0042-1757237
A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices
Funding None.
Abstract
With the advancement of clinical research and the increased burden on laboratory services, there is an unmet need for guidelines regarding proper laboratory functioning and reliable data generation. Several organizations from all over the world have published guidelines for these clinical and research laboratories. Good Clinical Laboratory Practices (GCLP) are stepwise procedures aimed at strengthening the quality of test results produced by all clinical laboratories engaged in human sample analysis. In this article, we attempt a comparison of the GCLP guidelines recently issued by the Indian Council of Medical Research with the guidelines released by the World Health Organization and the European Medicines Agency. Also, we have included and discussed several suggestions that, if included, will lead to the strengthening of the laboratory practices used for both research and patient care for overall improvement in the Indian healthcare system.
Authors' Contributions
Rajat Kumar Joshi was involved in planning, designing, data collection, manuscript writing, reviewing, and editing. Sudhir Chandra Sarangi was involved in planning, designing, data collection, manuscript writing, reviewing, and editing.
Soumya Ranjan Mallick, Sarita Mohapatra, and Sudip Kumar Datta wrote, reviewed, and edited the manuscript.
Publication History
Article published online:
20 October 2022
© 2022. The Indian Association of Laboratory Physicians. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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