ONDQA View on Implementation of QbD: Successes & Remaining Challenges

• The technical and economic value of QbD have been demonstrated (Ref. ISPE Survey by D. Kourti & B. Davis) • Application of QbD principles have been widely adopted by industry for small molecule development. • There have been challenges with implementation of QbD in regulatory submissions, i.e., post approval protocols. • There is an opportunity to leverage learning from the joint EMA/FDA Parallel Pilot Program via harmonized Q & A.