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 Research Compliance Administration of the Office of Research Administration, Indiana University Purdue University Indianapolis is charged with ensuring that the University is aware of and monitors all manufacturing and testing labs for GMP / GLP compliance. As development continues on the Office of Research Administration site, additional information on GMP / GLP will be added here.
For further information, please contact Research Support Services, firstname.lastname@example.org, 317-278-7189.