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Title : QUALITY BY DESIGN (QBD): AN EMERGING PARADIGM FOR DEVELOPMENT OF PHARMACEUTICALS
Authors : Rakesh A. Chaudhari, Ashok P. Pingle, Chetan S. Chaudhari, Chetan Yewale, Kantilal A. Patil
Abstract : Quality by Design (QbD) refers to a holistic approach for development of quality pharmaceutical products, it is an essential part of the modern approach to pharmaceutical quality, QbD is a major challenge to the Pharmaceutical industry whose processes are fixed in time, despite inherent process and material variability, under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product Profile (TPP), Quality Target Product Profile (QTPP)] and identify critical quality attributed (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability. This paper discusses the pharmaceutical QbD and describes how it can be used to develop the pharmaceutical products well within the specified period of time.

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