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@article{184001,
        author = {Ms. Dhopre Aishwarya  N. and Mr.Pathan Ayaj S. and Ms Swami Vaishnavi B and Ms Mokashe Vaishnavi N. and Mr. Pathan Aslam H and Mr. Gaikwad Rushikesh S.},
        title = {An Overview of Quality by Design (Qbd) in Pharmaceuticals},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {3},
        pages = {3825-3832},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=184001},
        abstract = {Quality by Design (QbD) has emerged as a transformative approach in pharmaceutical development, aimed at building quality into products from the very beginning rather than testing it at the end. This systematic, science- and risk-based framework emphasizes a thorough understanding of processes, materials, and product performance to ensure consistent quality throughout a drug’s lifecycle. Quality has been given an importance by all regulatory bodies for pharmaceutical products. Quality means customer satisfaction in terms of service, product, and process. The QbD paradigm integrates principles such as defining a Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), and establishing a robust Design Space through risk assessments and Design of Experiments (DoE). Regulatory bodies like the FDA and ICH have strongly endorsed QbD to enhance product efficacy, safety, and regulatory compliance. This review outlines the core elements of QbD, discusses its implementation strategies across different stages of drug development, and highlights the benefits and challenges associated with its adoption. Ultimately, QbD enables more efficient development, continuous improvement, and greater assurance of quality in pharmaceutical products. The analysis was per formed in view of an improved standardization between research teams, and should contribute to reduce the gap towards compliant Good Manufacturing Practice (cGMP) manufacturing.},
        keywords = {Quality By Design, Critical Quality Attributes, Pharmaceutical Analysis, Quality Target Product Profile},
        month = {August},
        }