QUALITY-BY-DESIGN (QBD) IN PHARMACEUTICAL DEVELOPMENT

Authors

MS. PRAKRITI DIWAN UPADHYAY, Associate professor, Danteshwari College of Pharmacy, Borpadar, Jagdalpur, 494221; DR. RITESH KUMAR, Associate Professor, Sharda School of Pharmacy, Sharda University Agra, Uttar Pradesh, India, Pin- 282007; DR. RESHU TIWARI, Assistant Professor Faculty of Pharmacy, Integral University, Lucknow (UP) 226022; Dr VINAY SAGAR VERMA, Associate professor Kamla Institute of Pharmacy, Shri Shankaracharya Professional University (Previously known as Faculty of Pharmaceutical Sciences, Shri Shankaracharya Technical Campus) Pincode: 490020; DR. FARAH DEEBA, Assistant Professor, Sharda University, Plot no 32,34, Knowledge Park-III, Greater Noida, Ruhallapur, Uttar Pradesh 201310

Synopsis

 

Quality-by-Design (QbD) is a modern, science-driven approach that redefines pharmaceutical development by embedding quality into every stage of the product lifecycle. Rather than relying solely on end-product testing, QbD emphasizes a proactive understanding of processes and risk management to ensure consistent product performance and regulatory compliance.

???? Key Concepts:
  • Systematic Development: Begins with a predefined Quality Target Product Profile (QTPP), guiding formulation and process design to meet therapeutic goals.
  • Critical Quality Attributes (CQAs): Identifies essential product characteristics that must be controlled to ensure safety, efficacy, and stability.
  • Design Space & Control Strategy: Establishes a multidimensional range of acceptable process parameters and material attributes, allowing flexibility without compromising quality.
  • Risk Management: Applies tools like Failure Mode Effects Analysis (FMEA) to anticipate and mitigate risks throughout development and manufacturing.
  • Real-Time Release Testing (RTRT): Enables in-process monitoring and control, reducing reliance on post-production testing and enhancing efficiency.
  • Regulatory Alignment: Supported by ICH guidelines Q8, Q9, and Q10, QbD fosters transparency and smoother regulatory submissions.
???? Impact & Future Outlook:

QbD enhances product robustness, reduces batch failures, and accelerates time-to-market. As technologies like AI, PAT (Process Analytical Technology), and Industry 4.0 evolve, QbD is poised to become the cornerstone of next-generation pharmaceutical innovation.

 

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Volume

COMPUTER AIDED DRUG DEVELOPMENT

Pages

50-96

Published

July 16, 2025
Copyright (c) 2025 Dr. I. Somasundaram, Mr. Praveen Sekar, Ms. Rohini Armo, Dr Bhupen Kumar Baruah (Volume editor); MS. SNNEHAA BHOSLE, NEHA ARORA, MONU KUMAR (MK GROVER), DR. T. DEBORAH PARIPURANAM, DR. AVINASH JORIYA, SANOBER PARVEEN, MR. YOGESH MATTA, MS. DHANASHRI DEVENDRA BORAWAKE, DR. URMILA RAGHUVANSHI, AISHWARYA JHALA, DR. THENRAJA SHANKAR, DR. A JULLIYAN DILLEBAN, MR. GADGE SHUBHAM CHANDRAKANT, DR. LAKSHMI, DR. S. REGHA, DR. VELENTI CHAUHAN, DR. MOIDUL ISLAM JUDDER, DR. MONIKA RAKSE, V. GEETHA, DR. MUKESH KUMAR MEENA, MS. PRAKRITI DIWAN UPADHYAY, DR. RITESH KUMAR, MS. SHRADDHA DINGARE, MS. KHANAPURE PRITI PARMESHWAR, DR. A JULLIYAN DILLEBAN, MS. PRAKRITI DIWAN UPADHYAY, DR. RITESH KUMAR, DR. RESHU TIWARI, Dr VINAY SAGAR VERMA, DR. FARAH DEEBA, MR. SHOUVIK MONDAL, MR. OMPRAKASH B, DR. KAVITHA S PATIL, MAYANDIGARI GURUVAREDDY, DR. JAYASANKAR NARAYANAN (Chapter Author)

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How to Cite

UPADHYAY, M. P. D. ., KUMAR, D. R. ., TIWARI, D. R. ., VERMA, V. S. ., & DEEBA, D. F. (2025). QUALITY-BY-DESIGN (QBD) IN PHARMACEUTICAL DEVELOPMENT. In Dr. I. Somasundaram, M. B. K. . Baruah, M. P. . Sekar, & M. R. A. Armo (Eds.), COMPUTER AIDED DRUG DEVELOPMENT (pp. 50-96). Nexus Knowledge Publication (Imprint of AKT Multitask Consultancy). https://nknpub.com/1/catalog/book/8/chapter/20