Current Scenario and Future Perspective of Good Laboratory Practices

Pharmaceutical laboratories are operated based on standards and regulations. These standards aim to safeguard the safety, efficacy, and quality of pharmaceutical products. During the conduct of laboratory practices, ethical principles must be considered and followed. These practices are followed according to the regulations and standards set by the Food and Drug Administration (FDA) and the Organisation for Economic Co-operation and Development (OECD). The OECD’s principles of Good Laboratory Practices (GLPs) are international guidelines that focus on performing research studies and non-clinical testing. Pharmaceutical industries need to comply with current Good Laboratory Practices (cGLPs) guidelines to ensure that the pharmaceutical products that are produced are of higher than expected quality. This chapter discusses the different principles in different fields of science and their future regulations. These practices are important for protecting health and ensuring the safety of both animal and human subjects. It also emphasizes 21 Code of Federal Regulation (CFR) Part 58 for nonclinical laboratory studies conducted to support and submit data for permissions for marketing or research on regulated goods by the FDA. Part 58 of 21 CFR provides an overview of FDA GLP regulations, which includes Subparts A to K. These research studies establish a framework regarding the handling and organizing of laboratory activities. The established framework should ensure that the data produced can be used for decision-making regarding the effectiveness of pharmaceutical products. GLPs can be made better to improve the efficacy as well as accuracy of nonclinical studies through the help of OECD principles of GLP in various countries.