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. 2025 May 8;17(5):623. doi: 10.3390/pharmaceutics17050623

Table 8.

Categorization of QbD Tools Across Pharmaceutical Development Stages.

QbD Stage Key Activities Associated Tools/Methodologies
1. Product Design
  • -

    Conceptualization and research for consistent quality
  • -

    Critical Quality Attributes (CQAs) definition

  • -

    Design of Experiments (DOE)

  • -

    Multivariate analysis

  • -

    Process Analytical Technology (PAT) (real-time monitoring of dissolution, etc.)
2. Process Design and Optimization
  • -

    Scalable manufacturing process development

  • -

    Process synthesis (continuous, batch, semi-batch)

  • -

    Process modeling (CPP definition)

  • -

    Real-time control and risk mitigation
  • -

    PAT integration (CQA/CPP monitoring)

  • -

    Failure Mode and Effects Analysis (FMEA)

  • -

    Hazard Analysis and Critical Control Points (HACCP)

  • -

    Model Predictive Control (MPC) (real-time optimization)
3. Continuous Improvement and Control
  • -

    Ongoing optimization via real-time data feedback

  • -

    Adaptive control for process variations
  • -

    PAT-driven data analytics

  • -

    Continuous monitoring systems

  • -

    Adaptive control strategies