Pharmacy Courses

QbD and DoE in Pharmaceutical Development

QbD is ta systematic approach to product and process development that ensures high-quality products from the beginning, identifies critical quality attributes (CQAs), controls variability, and uses scientific principles for consistent and reliable manufacturing. 

Key features of QbD:

  • Product and process understanding including the identification of critical process parameters (CPPs) and critical material attributes (CMAs).
  • Risk assessment and mitigation and control measures.
  • Establishes a Design space (multidimensional combination and interaction of input variables) and control strategy to maintain the process within the design space.

Work Flow:

  • Define the Quality Target Product Profile (QTPP),
  • Identify CQAs, Identify CMAs, Identify CPPs,
  • Establish a Design Space,
  • Develop a Control Strategy,
  • Conduct Risk Assessment and Mitigation and 
  • Implement Continuous Improvement and Knowledge Management.

Related: A Brief Discussion on QbD Tools

Tools used:


2) Failure Mode and Effects Analysis (FMEA)

3) Fishbone Diagram (Ishikawa Diagram)

4) Control Charts

5) Risk Assessment Matrices

6) Statistical Analysis Software

7) Quality Tools (e.g., Pareto Analysis, Cause-and-Effect Diagram)

8) Process Analytical Technology (PAT)


Lead to more consistent and higher quality products with increase in process efficiency, and reduce costs associated with quality issues thus reduce the risk of product recalls and helps to have less changes in the life cycle management.

DoE is a statistical technique that systematically investigates process variables and their impact on output using factorial designs, response surface methodology, and statistical analysis to optimize performance and improve product quality.


Key aspects of DoE:

  • Factorial designs to study multiple factors and their interactions simultaneously, allowing for the accurate estimation of main and interaction effects.
  • Response surface methodology (RSM) to optimize factors and responses, leading to the identification of optimal settings for desired outcomes.
  • Statistical analysis techniques to reveal critical factors and their effects, providing valuable insights for process improvement and product optimization.


Ability to save time and resources by identifying the optimal process conditions and reducing the number of experiments needed. This can lead to faster development timelines and reduced costs.

In summary, QbD is an approach to product & process development that focuses on understanding and controlling CQAs, DoE is used as a tool within the QbD framework to support the identification and optimization of critical factors that influence product quality. While these may require a significant investment of time and resources, the long-term benefits make it a worthwhile endeavor for companies looking to improve their product quality and customer satisfaction.


Resource Person: Bharathi Kodali

Previous Post Next Post