Understanding Post-Approval Changes
FDA has made a number of recent changes to its regulations concerning post-approval manufacturing changes for drug products. This course covers categories of post-approval changes (PAC), the requirements for each, and PAC guidance. Topics in this course include: SUPAC, Components and Composition, Site of Manufacture, Scale of Manufacture, and Manufacturing. After completing this course, learners will be able to recognize the requirements related to PAC and FDA guidance for those requirements.
After this course learners will be able to recognize pac guidance and how these documents are used to provide notification to fda for post-approval changes to an approved drug application. identify the categories of pac and the recommended chemistry, manufacturing, and control (cmc) requirements for each change. identify the tests and documents needed for each category of change.