A Comparative Review of ICMR, WHO, and EMA Guidelines for Good Clinical Laboratory Practices.

IF 0.9 Q3 MEDICINE, GENERAL & INTERNAL Journal of Laboratory Physicians Pub Date : 2023-06-01 DOI:10.1055/s-0042-1757237
Rajat Kumar Joshi, Sudhir Chandra Sarangi, Sarita Mohapatra, Saumyaranjan Mallick, Sudip Kumar Datta
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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.

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ICMR、WHO和EMA良好临床实验室规范指南的比较回顾
随着临床研究的进展和实验室服务负担的增加,关于适当的实验室功能和可靠的数据生成的指南的需求尚未得到满足。来自世界各地的几个组织已经为这些临床和研究实验室发布了指南。良好临床实验室规范(GCLP)是旨在加强所有从事人体样本分析的临床实验室产生的检测结果质量的逐步程序。在本文中,我们试图将印度医学研究理事会最近发布的GCLP指南与世界卫生组织和欧洲药品管理局发布的指南进行比较。此外,我们还包括并讨论了一些建议,如果包括在内,将导致加强用于研究和患者护理的实验室实践,以全面改善印度医疗保健系统。
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来源期刊
Journal of Laboratory Physicians
Journal of Laboratory Physicians MEDICINE, GENERAL & INTERNAL-
自引率
0.00%
发文量
99
审稿时长
31 weeks
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