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Abstract

The process of developing innovative, safe, and effective treatments is time-consuming, difficult, and expensive. The use of a Quality by Design approach, which emphasizes incorporating quality into pharmaceutical products during the design phase rather than testing, has resulted in higher product quality, reduced costs, and a shorter time to market. According to the guidelines of the International Council for Harmonization, quality by design is a methodical approach to medication development that begins with defined objectives. This scientific and data-driven, risk-based approach advances pharmaceutical development, production, and quality assurance. The two fundamental components of quality by design -quality risk management and knowledge management -work together to create an organized and efficient path to consistent pharmaceutical product quality. In this review, the impact of QbD on pharmaceutical products has been examined and reviewed by using data, which collected by a comprehensive literature search on QbD, QbD applied dosage forms, quality risk management in pharmaceutical manufacturing, process analytical technology in any field Pubmed, ScienceDirect, ISI Web of Knowledge, Google Scholar, ICH related databases were used for research or review articles published in peer-reviewed journals from 2009 to 2025. For patent search, the European Patent Office (EPO) and the United States Patent, Trademark Office (USPTO), and the Google Patents databases were used. And, the concepts of quality risk management and knowledge management, which play an important role in quality by design, have also been presented with patents and recent developments in this field, in addition to future perspectives. In terms of industry application of the QbD approach, both for new and generic drug manufacturing processes are also examined.

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2025-07-21
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/content/journals/cchts/10.2174/0113862073388521250708101658
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An Up-to-Date Screening on the Tool of Quality by Design in Pharmaceutical Manufacturing
Bentham Science Publishers ; https://doi.org/10.2174/0113862073388521250708101658
/content/journals/cchts/10.2174/0113862073388521250708101658
/content/journals/cchts/10.2174/0113862073388521250708101658
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  • Article Type:     Review Article
Keywords: hazard and operability analysis ; quality risk management ; quality by testing ; Quality by design ; critical process parameters ; design space ; process analytical technology ; critical quality attributes

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