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- Title
Quality by Design -- A Tool for Pharmaceutical Industry that Has No Near End.
- Authors
JOSHI, ANUSHKA; RAJPUT, AISHWARYA; VERMA, PREETI; SRIVASTAVA, SHOBHIT PRAKASH; SHARMA, UTKARSH; MISHRA, SUDHANSHU
- Abstract
Quality by Design is a trending concept which is widely utilized for the optimization and development of pharmaceutical processes and products worldwide. Currently, the first and foremost concern of the manufacturers and product developers is to provide their customers with the most effective and quality product with the help of the available and most feasible resources. Quality by design concept is based on the ethos that quality is built in a product from the very beginning of the development and not by just testing or inspecting it in the end. This is a systematic and scientific approach that allows the developers to take into consideration all basic factors and variables that may affect the final output and create a robust process and product with the predetermined specifications. A large number of industries are shifting towards risk-based approach like QbD as per their convenience and due to regulatory requirements these days, though along with complete knowledge about the process, basic and advanced knowledge about various facets of this concept is equally important for its successful application. This review briefly describes the elements of quality by design including basic terms like CQAs, QTPP, design space along with advantages of this approach over the traditional approach. It also includes prospects and current challenges and barriers associated with the acceptance of this concept among pharmaceutical industries.
- Subjects
PHARMACEUTICAL industry; NEW product development; INDUSTRIES; HEALTH care industry; PRODUCT quality
- Publication
International Journal of Pharmaceutical Research (09752366), 2021, Vol 13, Issue 3, p77
- ISSN
0975-2366
- Publication type
Article
- DOI
10.31838/ijpr/2021.13.03.027