How to Make the Business Case for Quality by Design - No time for QbD? How to convince management to make it a priority. - BioPharm International


How to Make the Business Case for Quality by Design
No time for QbD? How to convince management to make it a priority.

BioPharm International
Volume 21, Issue 12

QBD Reduces Risk

By increasing process understanding, QbD reduces process risk and variability, and can move us toward real time quality assurance. Thus, building QbD into future manufacturing processes is one of the most important benefits of the effort undertaken by collaborative product development and manufacturing teams conducting retrospective data analysis.

The FDA knows that accurate and reliable predictions are a reflection of process understanding, which is inversely proportional to risk. A well understood process reduces the need for final product testing, because the process is under control while it is running, i.e., in real time, or relevant time. Parametric release, or real time release, is based on this idea that the more companies understand about their processes, the more assured the quality outcome, and the lower the risks to consumers.

Four years ago, the FDA also started a risk-based inspection program that offers fewer and less intensive inspections when a manufacturer can demonstrate process understanding that leads to better control of the variability in process outcomes through QbD. A site risk potential (SRP) score, developed as a way for the FDA to prioritize plants for inspection, is made up of facilities risk (e.g., establishment type and defect history), product risk (e.g., prescription, injectable, or over-the-counter drugs), and process risk (e.g., process controllability and contamination potential)—with the date of the last inspection factored in. Thus, making better choices when designing future manufacturing processes also can reduce the process risk portion of the SRP score and improve future inspection records. Of course, fewer inspections translate to large savings in time and money.

Therefore, the question at hand is clear: With these manufacturing and business benefits within reach, why aren't more companies embracing QbD as an essential part of their businesses?


As an industry, we need to move QbD initiatives forward by helping internal teams see potential benefits, so they will give QbD a higher priority. In September 2007, Aegis Analytical Corporation conducted a survey in collaboration with AMR Research to examine the industry's use of QbD.4

Figure 1. At what stage is the Quality by Design initiative at your company?
As Figure 1 shows, 58% responded that their QbD initiatives were only in the "ideas and vision" stage or "not started," while a mere 3% had rolled out the initiative across their organizations. So most organizations are "still thinking about QbD" as part of their corporate strategy rather than engaging in implementation.

Figure 2. What is the biggest obstacle to progress on a Quality by Design initiative at your company?
When asked about the biggest obstacle to progress on a QbD initiative, the largest factor was "too many other things to do" cited by 45% of respondents (Figure 2). This is a huge disappointment. How could this be? Presumably, we are all putting out fires and no one has enough time to look to the future. That reason was followed by "most people don't know what it is" and "management commitment" (both cited at 19%).

What this survey data may mean is that, so far, the business case for Quality by Design has not been successfully made in many companies. When there is a compelling business case for something, it's interesting how quickly it becomes a top priority. Surely, this can happen with QbD as well.

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