Quality by Design (QbD) Position for Acryl-EZE® Film Coatings

This document outlines Colorcon’s process for ensuring the quality and consistency of all Acryl-EZE systems, including Acryl-EZE II. Film coating using a fully formulated coating system is highly beneficial with reduced or no risk to drug product development, manufacture, and performance. As Colorcon strictly controls the raw material quality and color in the manufacture of its fully formulated film coatings, they are not considered to be a critical risk factor in Quality by Design (QbD) when conducting a holistic risk assessment. This document discusses the various controls to guarantee acceptable and repeatable product performance.