FDA Perspectives: Understanding Challenges to Quality by Design - Pharmaceutical Technology

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FDA Perspectives: Understanding Challenges to Quality by Design
Directors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.


Pharmaceutical Technology
Volume 35, Issue 9, pp. 60-64

Business case for quality by design


Figure 1: Conceptual timeline showing quality-by-design (QbD) versus traditional development.
The team's analysis shows a strong preliminary business case for QbD. Interviews proved false two commonly held beliefs that QbD is very expensive and will drive costs up and that QbD will take a long time and require much more analysis. Interviews provided evidence that the cost to implement QbD is in fact minimal and the increase in time, if at all, is negligible (see Figure 1).

Analysis also identified many potential benefits from QbD. In terms of quantifiable benefits, value comes from four main areas: a reduction of cost of goods sold and capital expense, increased technical development productivity, improved quality (and lower risk), and increased sales.

Ultimately, for companies to experience the most business benefits possible, two things must be in place: (1) companies must be aligned across the entire operating model to capture the full benefits that QbD enables in manufacturing and quality control, and (2) FDA must ensure a high quality and consistency of review and compliance (e.g., train reviewers, provide stronger guidance and ground rules for QbD filings) and deliver on the regulatory benefits many companies feel were promised.

Implications for FDA

As previously noted, the team's research highlighted many challenges to QbD implementation. In response, several options were provided to encourage and accelerate QbD adoption.

FDA policy options. Three options were provided under this category:

  • Define and codify incentives. Many companies felt this was a powerful way to encourage QbD adoption. As such, FDA may want to consider whether to do this and, if so, what those incentives should be and what benefits could come from introducing these incentives.
  • Develop tangible guidance for QbD execution. Companies—especially those in the early stages of adoption—were confused by what QbD means and how to execute such a huge endeavor. They strongly believed that they could benefit from more tangible guidance.
  • Determine whether to mandate implementation of QbD. If, within certain segments, there is a possible public health risk due to lack of scientific understanding by industry and the incentive to increase that understanding is limited, mandating QbD could be considered.

Internal FDA change management. Two options were provided under this category:

  • Ensure consistency of review process in terms of scientific knowledge and quality of review. The desire for a consistent review process and well-trained reviewers is unanimous throughout industry. FDA is aware of this need and continues to train and prepare reviewers to adequately assess QbD applications.
  • Harmonize how QbD is approached across FDA. FDA should present a unified approach to QbD to ensure that the momentum around QbD adoption in industry is strong.

External change management. Three options were provided under this category:

  • Enhance communication with industry. Industry almost universally asked for more frequent dialogs with FDA. The companies who participated in the Office of New Drug Quality Assessment's chemistry, manufacturing, and controls (CMC) pilot programs felt they benefited from the increased, and often less formal, communications. While increased levels of communication may pose constraints on FDA as they relate to resources, a system should be crafted that allows for a level of communication that is acceptable and manageable for both FDA and industry.
  • Create more buy-in by disseminating case examples. Industry asked for real, tangible examples of what applications FDA has approved or denied and why those decisions were made. FDA can work with companies whose applications have been approved to develop examples that are sensitive to proprietary information, as well as disseminate findings and tips on successfully navigating challenges.
  • Improve international harmonization. Companies felt that a lack of international harmonization was one of the consistent challenges. FDA should continue to seek opportunities to work with other regulatory bodies and ensure alignment on what QbD means, what QbD requires, and how regulatory flexibility can be granted.


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