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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence

IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
ISSN
0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Quality by design Approach in Indian Pharmaceutical Industry: A Brief Status Appraisal

Author: MANISH KAPOOR, KULDEEP CHAND ROJHE, NEERAJ MAHINDROO
Abstract: Quality by design (QbD) is a new-fangled and reliable means that has form an indispensable part in pharmaceutical quality obtaining approach. It is a systematic, practical and risk-based approach in pharmaceutical development. Regulatory authorities worldwide also approve the adaptation and execution of Quality by design approach in pharmaceutical development. QbD approach ensures safety, efficacy and quality of product with high level of productivity. It is a novel concept which encourages industries in understanding product and manufacturing process beginning with product development which intends chiefly in building quality in product, not by just testing it. This approach requires characterization of the desired product performance profile, Target product Profile (TPP), Target Product Quality Profile (TPQP) and identification of critical quality attributes (CQA). The approach facilitates the Pharma industry to build uniform quality products by monitoring and updating its manufacturing processes. The basis of the present brief review is to discuss about the perception of pharmaceutical Quality by Design (QbD) and also sum up its present status in Indian pharmaceutical industries.
Keyword: ICH guidelines, Quality by Design, Critical Quality Attributes, Food and Drug Administration
DOI: https://doi.org/10.31838/ijpr/2020.12.03.014
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