Understanding Post-Approval Changes

This course covers the definition and purpose of post-approval changes. In addition, it explores the four categories of change: Components and Composition, Scale of Manufacture, Site of Manufacture, and Manufacturing, and the requirements for each level of change. In this course, you will learn about PAC guidance and how these documents are used to provide notification to FDA for post-approval changes to an approved drug application. You will examine the levels of PAC and the recommended chemistry, manufacturing, and control (CMC) requirements for each level. You will also explore the categories of change. Finally, you will be able to identify the tests and documents needed for each level and category of change.