Industry Perspective of Evolution of Quality by Design In NCE Implementation

• The adoption & implementation of QbD principles during development has improved process understanding & assurance of product quality. • The adoption & implementation of QbD principles during development has improved process understanding & assurance of product quality. Adoption & implementation of QbD improves confidence in quality and could promote global regulatory harmonization. • Implementation of QbD in regulatory submissions and under regulatory review have been inconsistent. Improved clarity regarding regulatory expectations for post approval changes warrants alignment with regulatory commitments and change management.