Course Description:
Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing these impurities. This two-day course will provide current regulatory guidelines and USP <1469> Nitrosamine Impurities. A live demonstration of USP <1469> laboratory procedures is also included with this course.
The course provides an overview of nitrosamine sources including their formation from the presence of other impurities, how to eliminate or reduce levels of nitrosamines as well as tools to assess and control nitrosamines in drug substances and drug products. In-depth analytical procedures in USP <1469> will be covered including the use of the USP Reference Standards and precautions to be used during procedures. Risk assessment methodology as per ICH9, control strategy development, calculation of nitrosamine limits as per ICH M7 and test method performance characteristics will also be addressed.
Upon completion of this course, you will be able to:
- 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 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 that impact the 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>
Who should participate:
- Analytical R&D scientists
- QC scientists (DS, DP)
- QC managers
- QA staff who authorizes drug product release
- Regulators affairs staff