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Introduction to Quality by Design

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Introduction to Quality by Design (QbD)

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Abstract

The pharmaceutical sector is concerned with product efficacy, safety, and quality. FDA decided to implement various Designs of Experiments (DoE) in the pharmaceutical industries. Quality by Design helps in the development of high-quality products and guides to manage product quality across its entire life cycle. This method quickly gains popularity worldwide due to its many benefits and use of numerous high-quality statistical tools. QbD is a meticulous, proactive, risk-based strategy for pharmaceutical development that commences with predetermined goals and emphasizes product and process understanding and process control based on reliable research. The QTPP, knowledge of product and process design, scale-up, control strategy, and constant improvement are considered as crucial components of pharmaceutical QbD. After approval, during the product lifecycle management process, the competency of the product and the process is evaluated and continuously enhanced.

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Authors and Affiliations

  1. SIRT-Pharmacy, Sanjeev Agarwal Global Educational University, Bhopal, Madhya Pradesh, India

    Rakhee Kapadia

  2. Department of Pharmaceutics, Sandip Institute of Pharmaceutical Sciences, Nashik, Maharashtra, India

    Ganesh Shevalkar

  3. Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India

    Ushasi Das

  4. Alembic Research Center, Vadodara, Gujarat, India

    Vikas Singhai

  5. Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Maharashtra, India

    Dipak Bari & Chandrakantsing V. Pardeshi

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Editors and Affiliations

  1. Department of Pharmaceutical Sciences, Dr. H. S. Gour University, Sagar, Madhya Pradesh, India

    N. K. Jain

  2. University Centre of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, Punjab, India

    Neha Bajwa

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Kapadia, R., Shevalkar, G., Das, U., Singhai, V., Bari, D., Pardeshi, C.V. (2024). Introduction to Quality by Design. In: Jain, N.K., Bajwa, N. (eds) Introduction to Quality by Design (QbD). Springer, Singapore. https://doi.org/10.1007/978-981-99-8034-5_1

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