alexa Abstract | Glances into the Realm of quality by design (QBD) in Pharmaceuticals

International Journal of Drug Development and Research
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Abstract

The aim of this article is to provide the information of pharmaceutical Quality by Design (QbD) and describe how it can be beneficial to pharmaceutical quality. Now a day’s QbD is very essential to quality of pharmaceutical product. QbD helps the understanding of industry during product development, particularly building quality in, not testing it. Under QbD when a company design and develop a product it needs to explain Target Product Profile (TPP), Target Product Quality Profile (TPQP) and Critical Quality Attributes (CQA). This is helpful to observe the impact of raw materials Critical Material Attributes (CMA), Critical Process Parameter (CPP) on the CQAs. This empirical approach is very much influential to manufacturing and product development in comparison to the traditional approach. In modern science and typical quality based assessment of pharmaceutical the chemistry, manufacturing, and control of application of ANDA by implementing the QbD, leading to the transformation in case of product development. Finally the company need to improve and enhance their quality by controlling through its manufacturing process in a consistent way.

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Author(s): Abdurrahman Pramod Kumar Sharma Ankur Saxena

Keywords

Design Space, Critical Quality Attributes (CQA), Critical Material Attributes (CMA), Target Product Quality Profile (TPQP), Critical Process Parameters (CPP)

 
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