In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert Panel

摘要

As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug product manufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability in CM. As such, the CM Working Group of the New Advancements in Product Performance Testing (NAPPT) Expert Panel was convened in 2019 to review the current standard for product performance testing, identify gaps in its applicability to CM, and recommend the development of new standards to support the adoption of advancing technologies industry-wide. 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.