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CDER flags missing IPCs and scale‑up evaluations for transdermal converting
Summary
FDA presenters said many submissions omit in‑process controls for release‑liner functionality and pouch integrity during converting, and urged sponsors to evaluate equipment capacity changes and revise residual solvent limits for commercial scale‑up.
Kokate identified converting as a process where sponsors often omit important in‑process controls (IPCs). He said IPCs for release‑liner functionality and pouch integrity are commonly missing from submissions and recommended including such IPCs to ensure final product performance.
He also advised sponsors to evaluate the impact of equipment capacity changes between exhibit and commercial batches and to revise residual solvent limits based on formulation and process capability. "When it comes to scale up equipment change, there could be an equipment capacity utilization difference between the exhibit batch and the commercial batch," Kokate said, and urged appropriate in‑process controls for scale‑up.
