Integrating Equipment Design, Logistics Processes and Real-Time Informatics: The Arrival of QbD in Pharmaceutical Logistics

Quality by Design (QbD) is a concept that has become mainstream in the pharmaceutical manufacturing space in recent years. QbD is a science- and risk-based approach to quality that identifies, measures and defines the critical processes that impact quality and provides a pathway to introduce quality and risk management into the design process. This webinar will discuss the Quality by Design process as it relates to logistics and evaluate its benefits.

The QbD concept within logistics cannot be implemented without an in-depth understanding of the equipment and processes by which critical pharmaceutical commodities are packaged and shipped. The key to QbD implementation is the ability to measure and preemptively control variation in real time using modern tools such as GPS-enabled data loggers. In addition to providing the ability to measure and understand the in-transit variation that exists, GPS data loggers collect critical data to help forecast, analyze and design process controls to eliminate the deleterious effects of the observed variation, using three basic activities:

1. Evaluate the actual performance of the equipment and in-transit processes
2. Compare the actual performance of the equipment and in-transit processes with goals
3. Act on any discrepancies observed during the in-transit process

Automating the risk management process through effective use of QbD using real-time informatics is a critical consideration when contemplating support of any commercial pharmaceutical product. Informatics that can capture, interpret and provide automated alerts and pre-defined escalation protocols based on the nature of the data captured for hundreds if not thousands of concurrent shipments will be critical in the effective launch of next generation therapies. QbD processes provide the foundation enabling such an approach to be effective.

Speaker

Mark W. Sawicki, Ph.D., Chief Commercial Officer, Cryoport

Mark Sawicki is chief commercial officer of Cryoport, a provider of end-to-end cold chain logistics solutions to the life sciences industry. Sawicki, who has more than 15 years’ experience in the pharmaceutical and biotechnology industries, holds a bachelor’s in biochemistry from the State University of New York at Buffalo and a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He also received graduate training at the Hauptman Woodard Medical Research Institute. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology

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