(52a) Progress in Implementation of Quality by Design - An FDA Perspective

Quality by Design (QbD) is a science and risk based approach for pharmaceutical process development and manufacturing that begins with first defining clinically relevant product attributes and then designing and implementing a process to consistently deliver quality product. Some key aspects of QbD implementation are: (a) execution of a comprehensive risk assessment to identify material and/or process parameters that affect finished product quality, (b) understanding of multivariate interactions of process parameters and material attributes, and (c) implementation of a robust control strategy to ensure consistent quality. Knowledge management is pivotal for successful implementation of QbD to ensure that process understanding is routinely monitored and updated throughout the product life cycle.

Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, many QbD containing applications have been submitted, reviewed, and approved, both within and outside of the pilot. The objective of this presentation is to provide insight about the current state of QbD implementation as garnered from the QbD applications submitted to date. In addition, some remaining scientific and regulatory challenges will be discussed.