Quality Improvement Office

FDA QA Oversight

Food and Drug Administration (FDA) Quality Assurance (QA) Oversight for
Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

The Office of Research Compliance (ORC), Quality Improvement Office (QIO) provides oversight of the Quality Assurance (QA) systems at Indiana University and offers support to clinical and nonclinical laboratory research investigators at the institutional level and provides the infrastructure for the highest level of FDA compliance. Assistance is provided with the navigation of and compliance with specific FDA-regulated processes, including research involving experimental drugs and devices, as well as pre-clinical laboratory studies.

For Good Clinical Practices (GCP) and IND - IDE questions and related information please see Human Subjects Research QA/QI and IND - IDE in the left navigation panel.

The FDA QA Oversight program supports currently funded and future Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) for FDA regulated nonclinical research studies and manufacturing at Indiana University (IU). The institution adopted a decentralized structure of compliance oversight to allow for essential support of ensuring the quality and integrity of nonclinical laboratory research studies and manufacturing Quality Assurance (QA) activities. The decentralized oversight model requires Individual functional areas of research to establish compliant processes, procedures, QA and governance structure.

Prior to initiating FDA regulated nonclinical laboratory research or manufacturing, please contact the Quality Improvement Office via the information listed under 'Contact Us' to the left of this page for assistance.

Good Laboratory Practices (GLP)

Good Laboratory Practice (GLP) is the organization, process and conditions under which FDA regulated nonclinical laboratory studies are planned, performed, monitored, recorded and reported. These practices are intended to promote the quality and validity of test data, as well as the traceability and integrity of data. Nonclinical studies should be performed under GLP conditions if they are intended to support applications for research or marketing permits for products regulated by the FDA. This research could include human and animal drugs, medical devices for human use, biological products, or electronic products.

Before initiating a study requiring compliance with the GLP standards on Indiana University campuses, you need to review 21 CFR 58 to ensure you can meet established regulatory standards. The investigator is responsible for complying with all associated requirements of GLP regulations, to include quality assurance, study design, oversight requirements, reporting and archiving requirements and the costs related to compliance.

In addition to reviewing the regulations, the FDA Guidance for Industry: GLP Regulations Management Briefings Post Conference Report may be helpful in understanding the scope of the regulations. You will find this and other publication links in “Resources.”

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product and ensure that the products consistently meet applicable requirements and specifications. GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. There are many different ways of fulfilling GMP requirements which allows for the manufacturer to decide how best to implement the necessary controls.

Before initiating a study requiring compliance with the GMP standards on the Indiana University campuses, you need to review the applicable regulations to ensure you can meet the established regulatory standards.

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