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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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

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

July - September 9[3] 2017

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An Overall Review of Quality by Design Approach

Author: KALAIVANAN , MITHRA CHANDRASEKARAN, ARUN RADHAKRISHNAN
Abstract: At present, In the pharmaceutical industry, the quality by design approach is widely used to obtain products with reliability and efficacy.Quality by design allows us to understand both product and process control through clear research and quality risk management. As QbD helps in building quality in all pharmaceutical products, it widely practised. But it may also be a drawback for few industries in which processes are fixed in time. It is one of the growing area which helps maintaining high quality standards and real time release of the drug product. To deliver a product performing its intended action by maintaining its quality, is the prime aim of pharmaceutical development. Implementation of QbD is widely encouraged by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH). This study explored the pharmaceutical QbD and discusses how it can be used within the specified time frame to produce pharmaceutical products efficiently. In this review , a brief overview about QbD and its elements such as quality target product profile (QTPP) critical quality attributes (CQAs), Quality Risk management (QRM), Control strategy and continual improvement will be discussed. Moreover, an overview about water as a QbD element was also discussed. Understanding the concepts of QbD is essential as most of the pharmaceutical industry are moving towards implementing QbD in their area. So, QbD will act as a bridge between drug application review and risk- based drug development.
Keyword: QbD, Pharmaceutical industry, Quality, Risk management, Process control.
DOI: https://doi.org/10.31838/ijpr/2021.13.01.396
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