(607g) Control Strategy for Manufacturing of Modified Release Capsules: A Regulatory Perspective

Sun, Z. - Presenter, Office of Generic Drugs, OPS, CDER, FDA

Compared to simple dosage forms, there will be more challenges for modified release dosage forms to assure high drug product quality as well as manufacturing consistency due to its complexity of formulation design and process development. Quality by design (QbD) provides an effective tool to systematically evaluate, understand, and refine the formulation and manufacturing process to ensure predefined product quality. In this presentation, the modified release capsule manufacturing process will be used as an example to illustrate how to implement the QbD principles to enhance process understanding and to improve process controls in order to provide assurance of reproducible commercial manufacturing for consistent product quality.  The purpose of this talk is to provide a regulatory perspective with regard to the QbD based control strategy for manufacturing of modified release drug products.