ICMR- Good Clinical Laboratory Practices (GCLP)-2021

'The Good Clinical Laboratory Practices (GCLP) Guidelines, 2021 is a revised document by the Indian Council of Medical Research (ICMR) to establish minimum criteria for clinical and research laboratories involved in examining human samples. The guidelines aim to ensure timely and accurate processing of biological samples enabling early and accurate diagnosis and patient safety leading to desired clinical outcomes. The GCLP compliance empowers clinical laboratories and clinical researchers to provide data/reports that are reliable and reproducible. The guidelines cover various aspects such as laboratory design, personnel training, equipment, reagents, pre-examination processes, sample acceptance/rejection, examination processes, release of test results, sample storage/disposal, safety in laboratories, ethical considerations, quality management, internal quality control, external quality assessment, risk management, and data management. The guidelines also emphasize the importance of following biomedical and waste management guidelines to ensure safe disposal of contaminated waste and safety of health workers and the community. The ICMR has constituted an Advisory Committee to develop these guidelines, which are expected to be adopted uniformly in medical laboratories involved in clinical research and/or patient care in India.'