Description
Opportunity Reference Code: FDA-CDER-2024-1366
*Applications will be reviewed on a rolling-basis.
CDER Office/Lab and Location: A research opportunity is available in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Pharmaceutical Quality (OPQ). The Office of Pharmaceutical Manufacturing Assessment (OPMA) evaluates drug product manufacturing process including the risk of presence of Process Equipment Related Leachables (PERL) in the drug product within the Food and Drug Administration (FDA) located in Silver Spring, Maryland. The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.
Research Project: The project involves manufacturing condition information and assessment outcomes of the equipment are not easily accessible, analyzed, and cross-referenced. The aim of the project is to establish a searchable database that collates manufacturing equipment with mitigated PERL risks and the relevant manufacturing conditions. The database will be used to assist risk-based assessment of drug product manufacturing process and improve assessment consistency.
Under the guidance of the mentor, the participant will learn the concept, principles, and regulations underlying quality assessment of drug product manufacturing process, especially those related to Process Equipment Related Leachables (PERL). The participant will also learn data and knowledge management enabling quality assessment using all available knowledge. This research will allow the participant to develop proof-of-concept proposals for the use of data mining and predictive analytics to aid risk-based manufacturing equipment assessment.
