(746f) Considerations for Control of Manufacturing Processes for Transdermal Systems – FDA Perspective

FDA classifies transdermal systems (TDS) as complex drug-device combination products with unique critical quality attributes (CQAs). It is usually difficult to identify, characterize, and control TDS CQAs that maybe impacted by drug product manufacturing process. This presentation discusses considerations for developing a robust manufacturing process and control strategy for TDS and to ensure manufacture of consistent quality product throughout the lifecycle.

To start, we will classify transdermal manufacturing processes and discuss typical TDS CQAs. From there, we will highlight case studies demonstrating the identification, characterization, and adequate control of TDS CQAs. Discussion will focus on control strategy associated with typical unit operations employed for TDS manufacture e.g. mixing, coating, drying, die-cutting, pouching. For mixing, we will discuss control strategies for content uniformity and the microscopic arrangement of matter. For coating and drying, we will review control approaches for physical adhesive properties, permeation enhancer content, residual solvents, and residual adhesive impurities. We will also cover control strategies for complex die-cutting and pouching operations. Lastly, we will discuss control strategy considerations in the context of inspections and facility readiness. Case studies will be drawn from submissions reviewed by FDA’s Office of Pharmaceutical Quality (OPQ).