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TORONTO, ON--(Marketwired - June 23, 2017) - 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.
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:
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.
For more information or to register for this complimentary event, visit: Integrating Equipment Design, Logistics Processes and Real-Time Informatics: The Arrival of QbD in Pharmaceutical Logistics
Cryoport is the life sciences industry's most trusted global provider of cold chain logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR-T cells. Cryoport's solutions are used by points-of-care, CRO's, central laboratories, pharmaceutical companies, manufacturers, university researchers etc; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport's proprietary Cryoport Express® Shippers, Cryoportal™ Logistics Management Platform, leading-edge SmartPak II™ Condition Monitoring System and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts. For more information, visit www.cryoport.com.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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