DOI: 10.21276/ajptr
Fri, 21 Jun 2019

Quality by Design (QbD): A Modern Era in Pharmaceuticals

Swati A. Pagar*1, Dattatreya M. Shinkar1, Ravindra B.Saudagar1

1. KCT’S RGS College of Pharmacy, Anjaneri, Nashik, 422 213. Maharashtra, India.


Quality by design is an essential part of the modern approach to pharmaceutical quality. Quality by design (QbD) is more scientific, risk based, holistic and proactive approach in pharmaceutical development for FDA and pharmaceutical industry in drug development. Quality by Design (QbD) is everything you do to directly to promote,  prove safety,  efficacy  and  quality  of your product from proof of concept to the point at which costumer are buying on regular basics.  This novel concept of QbD promotes industries in understanding product and manufacturing process starting with product development which aims basically building quality in product, not by testing it. A company needs to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA) under this concept of QBD during designing and development of a product. On the basis of information obtained company can build consistent product quality by monitoring and updating its manufacturing processes. This systematic approach to product development and manufacturing has received a great deal from traditional approach. The purpose of present article is to discuss the concept of pharmaceutical Quality by Design (QbD) and describe how it can be help to ensure pharmaceutical quality.

keywords: quality by Design (QbD), Target Product Profile (TPP), Critical Quality Attributes (CQA), ICH guidelines. Food and Drug Administration (FDA)

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