Lyophilization is a complex process requiring deep knowledge of the API’s physical and chemical properties.
Misjudging critical parameters can impact product stability.
The Quality by Design (QbD) approach helps structure and control the process from the start—
a key asset for securing and optimizing pharmaceutical development.
On December 17, 2024, our team had the opportunity to take part in the SFSTP study session dedicated to Nitrosamines—an event that proved to be a key moment in deepening our understanding of this complex and evolving regulatory topic.
The feedback session was a real success, thanks in particular to the presentation by our colleague Lorraine Balin. Her clear and insightful overview of the major regulatory developments provided valuable guidance on best practices and future directions for the pharmaceutical industry.
To extend the impact of this session, we are pleased to share a visual summary highlighting the key regulatory milestones discussed during the event. This infographic serves as a concise and educational tool to revisit the essential takeaways from a day rich in knowledge and exchange.
