Paper Key : IRJ************324
Author: Pavan V. Salve,Akshay V. Shejul ,Ashish S. Shejul ,Tushar D. Zodpe ,Amruta H. Kakde ,Varun A. Toshniwal ,Pratiksha V. Bansode ,Vaibhavi V. Nisargandh
Date Published: 16 Nov 2024
Abstract
The contemporary strategy for pharmaceutical quality is called Quality by Design. It explains how to apply Quality by Design to guarantee pharmaceutical quality. This review outlines Quality by Design and identifies some of its components. Each unit operation's quality attributes and process parameters are determined. The advantages, possibilities, and procedures associated with pharmaceutical product quality by design are explained. Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems are the ICH Guidelines that serve as its foundation. Additionally, it explains how Quality by Design can be used to pharmaceutical research and manufacture. The goal of pharmaceutical development is to create high-quality products and manufacturing processes that reliably produce the desired results. Products cannot be assessed for quality; instead, quality ought to be incorporated into the design. It contains important quality criteria, the Quality target product profile, and important facets of Quality by Design. Additionally, it compares the quality of products via Quality by Design and by final product testing. The ICH Guidelines serve as the cornerstone of Quality by Design.