Nitrosamine Risk Mitigation: From Regulatory Expectations to Practical Implementation
Day 2 Supply & Formulation Excellence Stage
07/10/2026 14:15 - 14:40pm
Contributors
Bram Baert : Senior Director Regulatory Affairs - Capsugel
Sandrine Picco : Analytical Development Lead, Innovaform® Accelerator - Capsugel
As regulatory expectations evolve, many discussions around nitrosamine mitigation have become focused on a single question: “How low is low enough?” While nitrite reduction is an important mitigation strategy, achieving meaningful and sustainable risk reduction requires more than a specification. It depends on analytical confidence, manufacturing reproducibility, supply chain robustness and scientific collaboration.
This presentation explores how evolving regulatory expectations, analytical capability and manufacturing realities are reshaping nitrosamine mitigation strategies. Using controlled low-nitrite capsule development as a case study, we discuss why analytical confidence, customer-specific risk assessment and cross-functional collaboration are becoming as important as the specification itself.
The session will demonstrate that durable nitrosamine risk reduction depends not on the lowest reported nitrite level, but on a number you can both achieve and trust, supported by robust analytics, reproducible manufacturing and cross-functional collaboration across the pharmaceutical value chain.