Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing this impurity. In this course, attendees will gain an understanding of current regulatory guidelines and USP General Chapter <1469> Nitrosamine Impurities. USP <1469> laboratory procedure video tutorials are included with this course via an on-demand format.
This course includes an overview of nitrosamine sources including their formation from the presence of other impurities and how to eliminate or reduce levels of nitrosamines. Tools to assess and control nitrosamines in drug substances and drug products as well as in-depth analytical procedures in USP <1469> including the use of the USP Reference Standard and precautions to be used during procedures will also be covered. Risk assessment methodology as per ICH9, control strategy development, calculation of nitrosamine limits as per ICH M7 as well as test method performance characteristics will also be addressed.

Subject area:
Drug Products & APIs

Objectives (If applicable):
•Describe the background, scope and approach of USP <1469> Nitrosamine Impurities and applicable regulatory guidelines.
•Explain pathways and sources of nitrosamine formation along with risk assessment tools and a high- level process flow to develop a control strategies.
•Describe how to select the appropriate analytical procedures based on test method performance characteristics for nitrosamine methods
•Discuss the proper use and handling of the USP reference standard in the respective analytical procedures.
•Identify factors which impact sensitivity and selectivity of methods.
•Summarize key considerations, challenges and method conditions along with sample and standard preparation of the four test methods described in USP <1469>.

Target Audience (If applicable):
• R&D manufacturers
• QC managers
• QC staff scientists (DS, DP)
• Research scientists
• QA staff who authorize drug product release