alexa Abstract | GLP (Good Laboratory Practice) Guidelines in Academic and Clinical Research: Ensuring Protection and Safety


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Abstract

Laboratory testing is a science professionally conducted with rigorous statistical analysis, quality control, and extensive oversight. Despite of considerable advancements, error originates from the laboratory investigations continue to increase multi-fold annually. Continuous quality improvement strategy through regulatory guidelines like (GLP) could serve as a key for error reduction. GLP is a easily understandable, internationally accepted quality system, a crucial code essential academic research. GLP has become a mandatory in the laboratories involved in clinical research particularly it serves as a solid standard for registration and regulatory research settings. GLP consist of information, managerial suggestions, rules exclusively designed to reduce bias, discrepancy of results, promotes mutually accepted data which serve as a helpful tool in ensuring laboratory staff integrity, data reliability, sensitivity and test specificity and help the laboratory researchers to avoid unnecessary repeating of laboratory tests. GLP was initially adopted by USA as US-FDA-GLP and was accepted by OECD and without modifying the essence of US-FDA-GLP, GLP was practiced globally. In this review, we discuss the applications, objectives, training needs and focus on the amalgamation of different GLP guidelines and their advantageous in the field of clinical research and academic research.

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Author(s): R. Vijayaraghavan, S. Ashok, Jayanthi Swaminathan, G. Ramesh Kumar

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