Is Quality by Design (QbD) Stuck, Struggling, or Just Slow to Mature?

This is a guest blog post by Paul Thomas.  Paul is Senior Editor of Pharmaceutical Manufacturing magazine,, and He can be reached at, and followed on Twitter @PaulThomasPharm.

There has been a lot of discussion within pharmaceutical circles of late as to what’s ailing the Quality by Design (QbD) movement. There are those who say that nothing is. There have been some “striking success stories on how Quality by Design can reduce defects and variability,” noted FDA CDER’s Janet Woodcock at the DIA annual meeting in June. QbD is “a success story that is evolving,” she added.

Scientists and technical experts who understand the beauty of Process Analytical Technology (PAT) tools and QbD principles and practices say that implementing them is a no-brainer. To not do so is like building a house on sand, says Emil Ciurczak, a consultant and spectroscopy expert.

What nags at experts and FDA, however, is that despite the documented successes of early adopters, there is a sizeable segment of the industry that still seems to be ignoring PAT/QbD altogether, much less dragging its feet. In Pharmaceutical Manufacturing’s annual control and automation survey, approximately one-third of respondents in 2010 said that their companies had no plans to implement either PAT or QbD. Cost and time remain the primary concerns among these skeptics, though proponents of PAT and QbD (such as Pfizer’s Gerald Migliaccio) maintain that cost and time—specifically, the saving of both—are precisely why they should be implemented!

It’s a matter of changing an industry’s rigid mindset, which is no easy feet, says consultant Ali Afnan, a former key member of FDA’s PAT team. “The basis for meaningful dialogue with FDA or any regulatory agency remains the same: the ability to show process and product understanding, good science, and process control. How many drug manufacturers today have mastered even the rudiments of this language?”

Few, of course. How, then, to get everyone speaking and thinking the same, science-based language? Some have suggested that FDA and other regulators actually “mandate” Process Analytical Technology (PAT) and develop more stringent requirements towards encouraging QbD-based drug submissions. More regulation, of course, only exacerbates the mindset that favors compliance over science.

A more likely scenario is that a dedicated organization be started, and funded, to coordinate and reenergize the movement. One of the roadblocks for PAT/QbD, says Rick Cooley of Dionex Corp., “has been the absence of an organization staffed by full-time, PAT-experienced people to champion the cause for the industry. There have been many professional organizations (e.g., PDA, AAPS, ISPE, ISA, ASTM) and professional conference organizers (IQPC, Cambridge Healthtech, IFPAC, IBC, etc.) that have jumped on the bandwagon, but having these numerous organizations with PAT special interest groups and their numerous conferences may have diluted the effort below what is required for a critical mass, added to confusion over the PAT/QbD concept, and have possibly even slowed the progress rather than helping it move forward.”

Broken. Stuck. Dragging. Confused. Conflicted. So many adjectives have been used to describe where the PAT/QbD movement currently stands, but most experts still believe it has the potential to transform the way that drugs are developed and manufactured. It is just taking longer than anticipated.

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