Pharmaceutical Scientist US Food and Drug Administration Silver Spring, Maryland
The FDA conducts pre-approval inspections (PAI’s) as part of the drug application review process under compliance program 7346.832. PAI’s are conducted to ensure that the facilities involved in commercial manufacturing, testing, packaging, and other critical operations are capable of consistently manufacturing quality drugs and to verify that the regulatory data in the submission are accurate and reliable. The FDA’s Office of Pharmaceutical Manufacturing Assessment (OPMA) performs a risk-based assessment to make decision on the need for a pre-approval inspection for facilities included in the regulatory submission. Various risk factors that FDA considers during facility assessment and making a PAI decision will be discussed in this rapid-fire session. This session will help pharmaceutical industries better understand FDA’s facility assessment practices.