Developing impurities analytical methods with a quality by design approach

The presence of impurities, even at trace levels, may affect the quality, safety and efficacy of drug products. Impurities in a drug substance or drug product can arise from chemical synthesis, degradation, manufacturing, storage conditions, packaging, excipients or contamination. Analytical method development for impurity detection and quantitation is a necessary and often challenging task for pharmaceutical manufacturers. Risk-based approaches such as Analytical Quality by Design (AQbD) and Method Lifecycle Management (MLCM) can be implemented to develop fit-for-purpose and robust methods that improve the control of impurities.

In this webinar, Dr. Mark Argentine, senior research advisor at Eli Lilly and Company, will describe the following within the context of AQbD and MLCM:

  • Method Lifecycle Management concepts applied to impurity analysis
  • Impurity method development strategy leveraging AQbD principles
  • Concepts and considerations toward monitoring method performance
  • Case studies highlighting analytical knowledge gathering for analytical method development, method transfer, and routine method controls

Attendees of this webinar will learn:

  • AQbD principles and strategies applied to the development of impurity identification and quantitation methods
  • MLCM approaches to managing impurities and associated methods post development and post validation
  • Tools and procedures to control risks of impurities and associated method development

Who should attend:

  • Method developers involved with impurity analysis
  • Managers interested in reducing the cost of poor-quality methods

Attendance certificate

All webinar participants can download a certificate of attendance, and a learning outcomes summary document for continuing education purposes.


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Dr. Mark Argentine

Senior Research Advisor

Lilly Research Laboratories, Eli Lilly and Company

Moderator: Sarah Thomas

Editorial Team