Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and
Joana Galvão Duarte1, Maria Galvão Duarte2, Ana Paula Piedade3
1Doctoral Program in Biomedical Sciences, School of Medicine & Biomedical Sciences, University of Porto (ICBAS-UP), Rua Jorge Viterbo Ferreira 228, 4050-513, Porto, Portugal.
The AAPS Journal
|May 19, 2025
Summary
Quality by Design (QbD) offers a systematic, science-based strategy for pharmaceutical development, ensuring product quality and reducing variations. This approach enhances drug development and manufacturing processes, leading to consistent, high-quality pharmaceuticals.
Area of Science:
- Pharmaceutical Science
- Chemical Engineering
- Regulatory Science
Background:
- Traditional pharmaceutical development relies on trial-and-error, often leading to batch variability and recalls.
- A shift towards a more scientific, risk-based approach is necessary for consistent product quality.
- Quality by Design (QbD) provides a systematic framework to address these challenges.
Purpose of the Study:
- To explore the application of Quality by Design (QbD) in pharmaceutical research and development.
- To highlight QbD's role in manufacturing, quality control, and quality assurance.
- To provide a comprehensive introduction to QbD for industry professionals and researchers.
Main Methods:
- Review of Quality by Design (QbD) principles and methodologies.
- Analysis of QbD implementation in pharmaceutical R&D, manufacturing, and quality systems.
- Examination of the regulatory landscape governing QbD adoption.
Main Results:
- QbD ensures pharmaceutical products consistently meet predefined quality attributes, minimizing batch-to-batch variations.
- Strategic deployment of QbD elements and tools enhances product development and manufacturing efficiency.
- Identified advantages of QbD alongside persistent challenges in its widespread adoption.
Conclusions:
- Quality by Design (QbD) is crucial for developing high-quality pharmaceutical products through a systematic, risk-based approach.
- Adoption of QbD promotes regulatory compliance and reduces the likelihood of product recalls.
- This review serves as a guide for adopting QbD for superior pharmaceutical development and manufacturing.
Keywords:
pharmaceutical manufacturingpharmaceutical quality by designquality assurancequality controlresearch and developmentMore Related Videos
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