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Monali Bora*, Vishal Rasve, Poonam Ghorpade, Mahesh Kshirsagar, Kalpesh Tated.
SAJVPM’s, College of Pharmaceutical Sciences and Research Center, Kada Ashti, Beed, M.S., India.

Volume 10, Issue 3, Page 117-125.

*Author for correspondence

Quality by design (Qbd) is a modern approach to the quality of pharmaceuticals. It is describing the use of Qbd to ensure the quality of pharmaceuticals. In this review, Qbd is described as some elements. It is based on ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. It also gives definitions, and applications, in Qbd in the pharmaceutical industry development and manufacturing of pharmaceutical products. Quality by design is a treading concept that is widely utilized for the optimization and development of pharmaceutical processes and product development worldwide. A large number of industries are shifting towards risk-based approaches like Qbd as per their convenience and due to regulatory requirements these days .through along with complete knowledge about the process. This review has briefly described the elements of quality by design including basic terms like CPPs, CMAs, CQAs, QTPP, and design space along with advantages of regulatory bodies, regulatory challenges, and inspection & future perspective. It also includes prospects and current challenges and barriers associated with the acceptance of this concept among pharmaceutical industries.
Keywords: Quality by design, Risk management, ICH guidelines.