ABSTRACT
To ensure continuing product quality and performance characteristics of the semisolid topical formulations, regulatory approvals are required for changes to components or composition; manufacturing; scale-up/scale-down of manufacture; and site of manufacture of a semisolid formulation during the post-approval period. The effect that scale-up and post-approval changes may have on the stability of the drug product should be evaluated. Any equipment changes should be validated in accordance with current good manufacturing practices. The resulting data will be subject to examination by field investigators during routine good manufacturing practice inspections. The chapter presents the information in broad categories of unit operation. Under scale-up and post-approval changes, equipment within the same class and subclass are considered to have the same design and operating principle. A change from equipment in one class to equipment in a different class would usually be considered a change in design and operating principle.
