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Abstract
The principles of Good Laboratory Practices (GLP) are mainly intended for the laboratoriesperforming studies for regulatory compliance. However, today GLP can be applied to broaddisciplines of science to cater to the needs of the experimental objectives, generation of qualitydata and assay reprehensibility. Considering its significance, it can now be applied in academics;industries as well as government set ups throughout the world. GLP is the best way to promotethe reliability, reprehensibility of the test data and hence facilitates the internationalacceptability. Now it is high time to translate and implement the concept of GLP beyondregulatory studies. Thus, it can pave the way for better understanding of scientific problems andhelp to maintain a good human and environmental health. Through this review, we have made anattempt to explore the uses of GLP principles in different fields of science and its acceptability aswell as looking for its future perspectives.KVSP KNL1 GLPGOOD LABORATORY PRACTICESDEFINITION:1Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.INTRODUCTION2Good Laboratory Practice (GLP) is a quality system that is concerned with organizational process and conditions under which non clinical health and environment studies are planned, performed, monitored, recorded, reported and archived for risk assessment process (OECD, 1997). This quality system enables validity, reprehensibility as well as the reliability of toxicity testing data. US Food and Drug Administration (FDA) for the first time in 1978 introduced GLP regulations to eliminate fraud and poor laboratory activities in toxicity studies (Balderdash, 2003). Organization of Economic Cooperation and Development (OECD) introduced GLP guidelines internationally in 1981to facilitate different toxicity studies and to generate quality data for human and environmental risk analysis.The OECD guidelines cover organization, personnel, test facility, quality assurance system, test system, test item, standard operating procedures, performance recording and reporting of study under GLP principles (Turnheim, 1994). International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which provides the guidelines for the quality, safety and efficacy assessment of pharmaceuticals has mentioned GLP as a precondition for the successful registration of pharmaceuticals internationally (Cavero, 2009). Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) emphasizes that toxicological and Eco-toxicological studies should be carried out in compliance with the principles of GLP (Hulzebos et al., 2010). Further, the Globally Harmonized System (GHS) for the classification and Labeling of Chemicals, provides a framework for hazard communication on chemicals emphasizes on the need of GLP complied toxicological studies for the preparation of label and safety data sheet (Morita and Morikawa, 2011)
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Copyright © 2024 SHAIK JALEEL BASHA . This is an open access article distributed under the Creative Commons Attribution License.
