Beth H. Junker is the senior director of fermentation and development operations at Merck Research Laboratories
The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.
How to optimize facility utilization and improve plant performance.
Translate the concepts in to practical applications and reduce waste.
Supplemental tables for the above-mentioned article, providing additional information about the application of operational excellence methods.