The last seven years have brought, in rapid succession, a number of FDA initiatives designed to instill a more scientific basis into pharmaceutical quality assurance, drug development and manufacturing. The scope of many of these initiatives has been so broad and the pace of their introduction has been so fast (for FDA) that they may be more than a bit confusing.
Can you honestly distinguish between Design Space, Control Space, Design for Manufacturing, Quality by Design and Process Analytical Technologies (PAT)? (Take our online quiz and find out.) Consider PAT. For several years, FDA evangelists spread the word. Then, suddenly, PAT was quietly deposed and the new buzzword became Quality by Design (QbD).
Pharmaceutical Quality Systems, global harmonization and ICH Q8-10 are secondary themes, even though QbD is their cornerstone. Taking all these initiatives together, the overall quality picture can seem pretty vague, at times making it much easier to dismiss.
The consulting group AMR Research and the software firm Aegis Analytical surveyed industry professionals to see how they were progressing with QbD initiatives. They found that 74% of respondents already had QbD programs in place, or planned to initiate them within a year. However, the survey found that 72% were concerned that their colleagues didnt understand the differences between the various quality programs instituted by FDA over the past few years. In addition, 19% said that most people within their organizations dont know what QbD means and this is a major factor impeding adoption. Which begs the question: can you truly have a roadmap for QbD if youre not sure what the signs on the road are saying?
But there are other questions, too:
- Can you have QbD if FDAs field inspectors arent all engaged?
- Can you truly have QbD if management doesnt know what these signposts mean, or doesnt see QbD as a priority?
The survey also found that lack of management support impeded adoption of QbD. We have too many other things to do, responded 45%. Another 19% admitted that their management didnt promote QbD efforts. These programs are highly dependent on senior managements allocating the funding required for QbD, says Justin Neway, CSO of Aegis Analytical, Inc.
Failing to act poses risk, he says, adding, Companies will lose FDAs confidence if they show failures and dont avail themselves of information and technology.
However, a few key executives, even some C-level managers, are embracing the new quality paradigm. Wyeth President Charles Portwoods approach is to focus on Quality by Design as the priority and address the broader issues gradually. The only barrier to new quality systems is us, he said during an interview at the 2007 ISPE annual meeting (Article, p. 13). I sometimes worry that the industry is biting off too much with ICH 8, 9 and 10, and trying to go too far too fast. In contrast, I love Quality by Design, and Id like to see the industry focus on this principle, since it changes the traditional way of thinking and allows you to incorporate a risk-based approach.
Last June, ISPE launched a product quality lifecycle initiative (PQLI) to demystify new approaches to pharmaceutical quality and to offer practical suggestions for implementing ICH guidelines and establishing a QbD framework for regulatory submissions. The project is expected to take at least five years, and has started with global fact-finding sessions.
PQLI represents a breakthrough in many ways, particularly since it takes a product lifecycle approach to pharmaceutical product quality, says Aegis Neway. It also offers guidance for risk assessment and control. It should be interesting to see how the effort progresses.
In the meantime, perhaps the fine distinctions between different FDA initiatives are irrelevant after all. Focusing on QbD may be the best way to move your organization toward a new Quality Systems approach, while ROI may help convince management.
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