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Abstract

REVIEW ON QUALITY BY DESIGN (QbD)

Gayatri P. Gage, Mithun Rudrapal*, Anil G. Jadhav, Laxmikant B. Borse, Atul R. Bendale

Sandip Institute of Pharmaceutical Sciences, Sandip Foundation, Mahiravani, Trimbak Road, Nashik-422213, Maharashtra

ABSTRACT

Quality by design (QbD) is a new approach to the product development which offers important business benefits throughout the product life cycle. Now-a-days, QbD becomes an essential part in the pharmaceutical quality control process. ICH guidelines Q8 (pharmaceutical development), Q9 (quality risk management) and Q10 (quality systems) forms the basis of QbD. QbD defines the quality target product profile (QTPP), critical quality attributes (CQA), risk assessment and life cycle management to design and develops the formulation and process. The aim of this paper is to describe how QbD can be used to ensure the smooth manufacturing and quality of pharmaceutical products.

Keywords: QbD, ICH guidelines, Pharmaceutical, Quality control, Manufacturing, Design space, QTPP, AQbD.


[Full Text Article]