Paper Key : IRJ************753
Author: Ankita Jambe,Sujata Nirmal
Date Published: 14 Nov 2024
Abstract
QbD is a systematic approach to product development that aims to build quality into the product and its manufacturing process. Quality by design (QbD) is an essential part of the modern advance to pharmaceutical quality. Quality has been given an importance by all regulatory body for pharmaceutical products. Quality means customer satisfaction in terms of service, products,and process. QbD is best key to build a quality in all pharmaceutical products. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceutical Analysis. Under thisconcepts of be throughout design and growth of product, it is important to identify desire product performance report Targetproduct profile (TPP), Quality Target product profile (QTPP) and identify critical quality attributes (CQA).1 To recognize theimpact of raw material critical material attributes (CAM), critical process parameters (CPP) on the CQAs and identification an control sources of changeability. USFDA launched a pilot programme in 2005 to permit participating firms a prospect to submitchemistry, manufacturing, and controls (CMC) of NDA information representing application of QbD.