Business Case for Quality by Design
For decades, quality experts have promoted QbD as a way to improve manufacturing process outcomes. The life sciences industry has been slow to adopt the initative. Making a successful business case for QbD can be done by making the short and long-term business benefits clear.
New initiatives and technology are evaluated by decision makers based on how well they do the following:
• Support existing priorities
• Leverage existing investments
• Have a clear project definition and scope
• Offer near-term return to the bottom-line
Carefully relating a QbD initiative to these criteria can helpgain management buy-in.
Significant business and quality compliance benefits can be achieved through QbD when process development and manufacturing teams collaborate.To achieve these benefits, enabling technologies like Discoverant are also required.
For more information on this topics, please read Justin Neway's article in BioPharm Magazine, "How to Make the Business Case for Quality by Design."