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Quality by Design – A Tool for Pharmaceutical Industry that Has No Near End
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| Author:
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ANUSHKA JOSHI, AISHWARYA RAJPUT, PREETI VERMA, SHOBHIT PRAKASH SRIVASTAVA, UTKARSH SHARMA, SUDHANSHU MISHRA
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| Abstract:
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Quality by Design is a trending concept which is widely utilized for the optimization and development of
pharmaceutical processes and products worldwide. Currently, the first and foremost concern of the
manufacturers and product developers is to provide their customers with the most effective and quality
product with the help of the available and most feasible resources. Quality by design concept is based on the
ethos that quality is built in a product from the very beginning of the development and not by just testing or
inspecting it in the end. This is a systematic and scientific approach that allows the developers to take into
consideration all basic factors and variables that may affect the final output and create a robust process and
product with the predetermined specifications. A large number of industries are shifting towards risk-based
approach like QbD as per their convenience and due to regulatory requirements these days, though along with
complete knowledge about the process, basic and advanced knowledge about various facets of this concept is
equally important for its successful application. This review briefly describes the elements of quality by design
including basic terms like CQAs, QTPP, design space along with advantages of this approach over the
traditional approach. It also includes prospects and current challenges and barriers associated with the
acceptance of this concept among pharmaceutical industries.
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| Keyword:
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Pharmaceutical Science, Quality by design, Optimization, Critical process parameters, Method Development.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.027
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| Download:
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