Introduction To Scale-Up And Post-Approval Changes (SUPAC)

By Norm Fong, technical transfer manager, business development, WellSpring

Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. Among the things you should know about SUPAC (Scale-Up and Post-Approval Changes) is that it is not regulation, but only guidance. It relates only to drug manufacturing and it’s only available for certain dosage forms. That being said, it’s a very valuable tool in the scale-up process and the guidance does reflect the FDA’s current thinking. This is part 2 of an in-depth, multi-part series on product scale-up.