QbD Principles for Packaging Design and Stability: A Regulatory Perspective

Quality by Design (QbD) is a science and risk based approach for pharmaceutical manufacturing and development. Enhanced product understanding gained from following a QbD based approach, is increasingly being used to select packaging design parameters and to determine optimum storage conditions. The aim of this presentation is to illustrate, using relevant examples, various QbD based approaches that may be implemented for packaging design, determination of storage conditions and shelf life estimation and to offer a regulatory perspective regarding considerations for successful implementation of such approaches throughout the product life cycle.