QUALITY BY DESIGN: A PRE-REQUISITE FOR PHARMACEUTICAL DEVELOPMENTAbstract
Quality by Design (QbD) is an essential part of modern pharmaceutical development. QbD is a requisite for the design and development process for the pharmaceutical industry. QbD assists and encourages both the industries and FDA to inculcate a proactive, scientific and risk-based approach in the process and product development. It is based on a concept of building quality right from the start of the process rather than the final quality test of the finished product. An effective QbD approach provides insights and essential upstream throughout the development process which ultimately ends up offering a successful plan that reduces batch failures and recalls. It is also known as a structured lifecycle of product development and management. This review aims to present an overview of QbD implementation, its tools, elements, and methodologies, the involved ICH Guidelines, and the application in the current pharmaceutical sector. Under QbD, it is important to define the desired product performance profile i.e., Quality Target Product Profile (QTPP) and analyze, Critical Quality Attributes (CQA), Critical Process Parameter (CPP), Critical Material Attributes (CMA), and Control Strategies. It also assists in reducing down the total product development cost and time. Eventually, it has now turned out to be a quality standard for designing and launching new products.
Shweta Singh *, Sudha Rathod, Randeep Saini and Reshma Shaikh
Department of Pharmaceutics Oriental College of Pharmacy, Sanpada, Navi Mumbai (Affiliated to the University of Mumbai) Mumbai, Maharashtra, India.
28 January 2021
09 June 2021
21 June 2021
01 January 2022