What Does SUPAC Stand For?

SUPAC stands for Scale Up And Post Approval Changes

SUPAC, or Scale Up And Post Approval Changes, is a regulatory framework established by the U.S. Food and Drug Administration (FDA) to guide the pharmaceutical industry in managing changes made to manufacturing processes and product formulations after a drug has received approval. This approach aims to ensure that any modifications do not adversely affect the drug’s quality, safety, or efficacy, while facilitating innovation and efficiency in the manufacturing process. SUPAC provides guidelines that assist manufacturers in determining the necessary testing and documentation requirements for different types of changes, thereby streamlining the commercialization of pharmaceutical products.