Joshi Rajat Kumar, Sarangi Sudhir Chandra, Mohapatra Sarita, Mallick Saumyaranjan, Datta Sudip Kumar
Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
J Lab Physicians. 2022 Oct 20;15(2):179-186. doi: 10.1055/s-0042-1757237. eCollection 2023 Jun.
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.
随着临床研究的进展以及实验室服务负担的增加，对于规范实验室运作和生成可靠数据的指南存在未满足的需求。来自世界各地的多个组织已经发布了针对这些临床和研究实验室的指南。良好临床实验室规范（GCLP）是旨在提高所有从事人体样本分析的临床实验室所产生检测结果质量的逐步程序。在本文中，我们尝试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，我们纳入并讨论了一些建议，若将这些建议纳入，将有助于加强用于研究和患者护理的实验室实践，从而全面改善印度的医疗保健系统。
