• Vishal S. Nimkar
• Vaishnav D. Mandade
• Shivam V. kale
• Dr. Nilesh O. Chachda
• Khushi M. Kongre

Quality by Design (QbD) is an innovative approach aimed at improving pharmaceutical product quality through a systematic, proactive design process. This strategy integrates quality into every stage of product development, from formulation to manufacturing, rather than addressing quality as an afterthought. QbD is particularly important as regulatory agencies, such as the FDA, have emphasized its role in ensuring the consistency, safety, and efficacy of pharmaceutical products. The core of QbD lies in identifying and controlling Critical Quality Attributes (CQAs), which define the desired product characteristics. It also involves creating a Target Product Profile (TPP) and a Quality Target Product Profile (QTPP)to guide product development. By understanding how Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) influence CQAs, QbD allows manufacturers to anticipate and control variability throughout the product lifecycle. The introduction of QbDin the pharmaceutical industry was supported by initiatives like the FDA’s pilot program for New Drug Applications (NDAs) in 2005, which encouraged the industry to submit data on Chemistry, Manufacturing, and Controls (CMC). This approach, grounded in the ICH guidelines (Q8, Q9, and Q10), provides a framework for managing risk, ensuring product quality, and improving manufacturing efficiency. QbD is a transformative approach to pharmaceutical development, contributing to higher-quality products, more efficient manufacturing processes, and better regulatory compliance. Its application ensures that product quality is designed in, rather than inspected in, leading to more consistent and reliable therapeutic outcomes.

(QbD), (CQAs), (TPP), (QTPP), (CPPs), (CMAs), Pharmaceutical Development, Drug Manufacturing, Pharmaceutical Quality Systems, Regulatory Compliance, Risk Management, ICH Guidelines (Q8, Q9, Q10), (CMC).

""Quality by Design: A Novel Approach to Enhancing Pharmaceutical Product Quality"", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 12, page no.a281-a293, December-2024, Available :http://www.jetir.org/papers/JETIR2412027.pdf

""Quality by Design: A Novel Approach to Enhancing Pharmaceutical Product Quality"", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 12, page no. ppa281-a293, December-2024, Available at : http://www.jetir.org/papers/JETIR2412027.pdf