Good Laboratory Practices in Pharmaceutical Research: Regulations and Best Practices
Dasari Nikhitha Nikhitha
Paper Contents
Abstract
ABSTRACTThe term good practice is a set of principles that provides a framework for laboratory studies to be planned, performed, monitored, recorded, reported and archived. GLP governs non clinical studies conducted to evaluate the safety and efficacy of chemicals.1The term "good practice" indicates and established way of doing or performing of an activity in the way that is generally recognised as being the proper one. Good Laboratory Practices (GLP) in general symbolizes the "good practices" which need to be used in the laboratory, the purpose of which is testing the physical, chemical and microbial testing of materials as applicable and to avoid threat or hazardous to humans.2"Good Laboratory Practices "are a quality system, which establishes accurate documentation covering all aspects of a study and it's environment with regard to quality and integrity and reliability of safety data. The GLP have been formulated primarily to promote the quality and validity of test data used for determining the safety of the product.It also describes the recommended practices in judging for "positive" response and to avoid hazardous substances, which affect the environment, and finally human health.Keywords: GLP, FDA, OECD, EMA, Data management, Traceability, Documentation practices, Risk Management,
Copyright
Copyright © 2024 Dasari Nikhitha. This is an open access article distributed under the Creative Commons Attribution License.