As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug productmanufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability inCM. As such, the CM Working Group of the New Advancements in Product Performance Testing (NAPPT) Expert Panelwas convened in 2019 to review the current standard for product performance testing, identify gaps in its applicabilityto CM, and recommend the development of new standards to support the adoption of advancing technologies industrywide. This Stimuli article discusses the challenges and limitations of the current performance testing by dissolution for CM applications. It also presents recommendations on alternatives or surrogate methods, including in/at-line process analytical technology methods, with a decision tree to support users in identifying an option that is fit for their process. The Expert Panel seeks stakeholder feedback on the recommendations presented in this Stimuli article, and requests additional comments on the perceived challenges and limitations of performance testing.

• Vertex Pharmaceuticals
• Distek, Inc
• Merck & Co., Inc / U.S. Food and Drug Administration (FDA) / Bristol Myers Squibb / Eli Lilly and Company

• PAT
• Regulatory

1. BCS class
2. continuous manufacturing
3. decision tree
4. Dissolution
5. pat
6. product performance testing
7. regulatory
8. Stimuli Article