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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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Article In Press
Life review of elderly depression
Development and application of ATR-FTIR spectroscopy for mixture homogeneity in pharmaceutical application
The Increasing Damage in Tubular Cell of Infant Mice’s Kidneys from Carbofuran Exposure during its Mothers’ Lactation Period
Trend of transsexualism problem and its implications towards muslim community in Malaysia
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Evaluation of neurotoxicity of the ethanolic bark extract of Holarrhena pubescens Wall. ex G.Don in mice
Design, synthesis and evaluation of 2-aminobenzimidazole derivatives: strong candidate for PPAR gamma agonists.
Prediction of Heart Disease Using Feature Selection and Random Forest Ensemble Method
Strategies for Antiviral Drugs from Plants by Targeting the Hemagglutinin, Neuraminidase and other receptors of Influenza A virus
The impact of human resource and quality management in health care: A Review
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Introduction to QbD and its Application in Diverse Terrains

Author: DIVYA BISHT, SAMINATHAN J
Abstract: The assurance of quality, safety, and effectiveness of a product has dependably been essential from the customer and regulatory perspectives. QbD (quality by design) was an ideal approach to ensure quality products before US FDA (United States Food and Drug Administration) propelled cGMP (Current Good Manufacturing Practice) in 2002 and afterward ICH Q8 (pharmaceutical product development), Q9 (quality risk management) and Q10 (pharmaceutical quality system) guidelines were published exclusively emphasize QbD to ensure that the product quality should be built in by design. QbD as of late been expanding its domain at a winged pace getting across differing territories. In this paper, the basic knowledge of QbD, the elements (QTPP, CQA’s, CMA’s, CPP’s) of QbD, tools for QbD implementation, including risk assessment, Design of experiment (DOE), and Process Analytical Technology (PAT), are outlined brie?y. Moreover, the concrete applications of QbD in various industries are summarized and presented
Keyword: Control strategy, Elements, Design of Experiments (DOE), Process Analytical Technology (PAT), Quality by Design (QbD), Quality Risk Management (QRM).
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0.12
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