Compliance Services

GMP / GLP

Lab

Food and Drug Administration (FDA) Good Manufacturing Practices (GMP) have been defined as "the part of quality assurance which is aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use." GMP standards are the minimum methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug or medical device to ensure that the drug or device meets safety, identity, strength, quality, and purity characteristics that it purports or represents to possess.

Good Laboratory Practices (GLP) are the guidelines for quality control and quality assurance in testing laboratories. GLP methods deal with the organization, process, and conditions under which laboratory studies are planned performed, monitored, recorded, and reported. GLPs regulate all non-clinical safety studies that are intended to support applications for research or marketing permits for products regulated by the FDA, or by similar or other national agencies. This includes drugs for human and animal use but also aroma and color additives in food, biological products, and medical devices.

The Office of Research Compliance is responsible for the institutional oversight program structure, support and development as relates to GLP nonclinical laboratory research and GMP manufacturing.

An online module regarding good research practices is available through E Training. For further information, please contact Research Support Services, inforsch@iupui.edu, 317-278-7189.