Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment

To ensure continuing product quality and performance characteristics of the semisolid topical formulations, regulatory approvals are required for changes to

1. components or composition, 2. manufacturing (process and equipment), 3. scale-up/scale-down of manufacture, and 4. site of manufacture of a semisolid formulation during the

postapproval period.