We all understand the benefits of quality by design (QbD), don’t we? Maybe not. Justin O. Neway of Aegis Analytical made me reconsider my assumption that this was true. During his presentation about achieving manufacturing-process excellence, Neway cited a survey that asked manufacturers what the biggest obstacle was to progress on their QbD programs. The most common response (given by nearly half of respondents) was that they had too many other things to do.

Come again?

Neway was as surprised by this response as I was. What do you mean there are too many other things to do? Neway argued that the result of the survey showed that the business case for QbD has not been made successfully.

So let’s give it a shot. QbD captures product and process data during the development cycle of the pharmaceutical process. These data help researchers (and, later, manufacturers) gain process understanding, which enables you to predict product-quality attributes. When process understanding grows, you gain process control. And risk decreases as well.

That sounds good, but what kind of risk are we talking about? Risk to the manufacturer, for one thing. When producers understand critical process variables, they can control them and reduce the amount of out-of-specification product they create. Consistent quality can be achieved, and downtime can be reduced. Let’s not forget the regulatory relief companies enjoy when they demonstrate understanding and control of their processes.

But patients also benefit from QbD. When companies can reduce out of spec occurrences, they also reduce the likelihood of patient adverse events. The ongoing saga of contaminated heparin illustrates the importance of understanding your process and your materials.

Let’s recap: QbD brings process understanding and process control. Process control increases efficiency, provides regulatory relief, and yields consistent quality. These results mean safe and effective products for patients, which likely translates into profits for the manufacturer.

It seems like pharmaceutical manufacturers don’t have an excuse not to make time for QbD.