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Quality-by-design: are we there yet?

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Quality-by-Design (QbD) is widely adopted, with most users reporting frequent use of its tools. While QbD benefits patients and internal processes, a clear business case and consistent review efficiency perceptions remain areas for development.

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Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Regulatory Science

Background:

  • The Quality-by-Design and Product Performance Focus Group of AAPS surveyed QbD adoption and perception in 2012.
  • 149 responses were collected from industry (88%), academia (7%), and regulatory bodies (4%).

Purpose of the Study:

  • To assess the current state of Quality-by-Design (QbD) adoption and perceptions among pharmaceutical professionals.
  • To identify perceived benefits and challenges associated with QbD implementation.

Main Methods:

  • Anonymous survey distributed by the AAPS Quality-by-Design and Product Performance Focus Group.
  • Data collected from industry, academia, and regulatory professionals regarding QbD tool utilization and perceived impacts.

Main Results:

  • Majority reported high use of QbD elements (ICH Q8), with Design of Experiments, risk assessment, and Quality Target Product Profile as top tools.
  • Over two-thirds agreed QbD benefits patients and internal processes (knowledge management, decision making, lean manufacturing).
  • Over 50% of industry respondents were neutral/disagreed on QbD improving return on investment; differing views on review efficiency between industry and regulators.

Conclusions:

  • QbD shows broad adoption, but its full benefits and business case require further demonstration and stakeholder alignment.
  • Continued dialogue between industry and regulatory authorities is crucial for optimizing QbD implementation and review processes.
  • Academia reported significant influence of QbD on research, indicating its growing impact across different sectors.