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Good Laboratory Practices

Good Laboratory Practices (GLP) are a set of conditions that are required for conducting studies that support, or are intended to support, applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA). GLP regulations are set forth in Title 21, Code of Federal Regulations (CFR), Part 58, Title 40 CFR Part 160, or Title 40 CFR Part 792. Bioscience companies require that all non-clinical studies submitted for the development of a new drug be conducted under GLP conditions. A study is in compliance with GLP regulations when it has 1) a sound protocol, 2) qualified personnel to run the study, 3) standard operating procedures, 4) appropriate and adequate facilities, 5) calibrated and maintained equipment, 6) fully retrievable raw data, and 7) oversight and review by an independent quality assurance (QA) officer. In this course, students will learn about standard operating procedures, calibration and maintenance of laboratory equipment, how to maintain a laboratory notebook, validation of procedures and how to access, manipulate, and validate raw scientific data. At the conclusion of this course, students will have a firm understanding of how to perform scientific research in a regulated industrial setting.

Prospective employees who received GLP training would be extremely attractive to bioscience companies because it would ensure that experimental data generated by these individuals was collected according to industrial and Federal regulatory standards. Individuals with GLP training can be hired as entry level laboratory or manufacturing assistants and quality assurance and quality control associates.