Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation of N-Nitrosamines in many of these cases was linked to the synthesis and stability of the drug substance itself, it is well-documented that certain materials used in primary packaging can also be sources of N-Nitrosamine contamination. Examples include older grade elastomers and nitrocellulose laminated blister foils.
This webinar will explore the factors contributing to N-Nitrosamine contamination in drug products, emphasizing the role of primary packaging materials. Participants will gain insights into how these materials can introduce contaminants and the mechanisms behind N-Nitrosamine formation during storage and handling.
The session will cover the identification and mitigation of risks associated with N-Nitrosamine contamination. Attendees will learn about the latest regulatory guidelines and best practices for ensuring the safety of drug products. The presentation will also discuss strategies for selecting appropriate packaging materials to minimize the risk of contamination.
By understanding the sources and prevention methods for N-Nitrosamine contamination, participants will be better equipped to safeguard the quality and safety of their drug products. This knowledge is essential for professionals involved in pharmaceutical manufacturing, quality assurance, and regulatory compliance.