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Knowledge Management – The Life-Blood of Quality by Design
As announced in the April launch of the West NovaPure® products, West has employed Quality by Design (QbD) principles for the development and manufacture of key new products. An important aspect of QbD is knowledge management. Knowledge management, as defined in ICH Q10, is a “systematic approach to acquiring, storing, and disseminating information related to products, manufacturing processes, and components.” In other words, it is the life-blood of QbD. Without knowledge management, QbD becomes an event instead of an on-going process.
Every day that a product is being manufactured, there is something to learn about the process and the product. Capturing and sharing that information with operations, quality, and research and development is the value of knowledge management. The learning should make production better and improve the development of the next great product.
West has created a process for knowledge management that uses process owners, data repositories, data oversight and product reviews. The process is aided by a common location for information that is categorized in an intuitive manner. The end result is a living process for knowledge management that in turn keeps the QbD process moving forward. The on-going improvements to product and processes facilitated through the use of knowledge management is a benefit to West and its customers.
QbD does not stop at product launch; it continues throughout the product lifecycle. Knowledge management is key to the continuous improvement of the product and associated processes during the lifecycle. Knowledge management must be dynamic, changing and adapting to assure a high level of care. Products developed and manufactured using the principles of QbD and facilitated through the use of knowledge management help to assure that West understands and continues to meet customer requirements.
West and the diamond logo and By your side for a healthier world™ are registered trademarks or trademarks of West Pharmaceutical Services, Inc., in the United states and other jurisdictions.
NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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