Panoramic View on Quality by Design

Home > 2014, Vol. 2 No. 2 > Panoramic View on Quality by Design

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Authors

ManishaDepartment of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, India
Swagat TripathyApotex Research Private Limited, Banglore – 560 099, India
Harish DurejaDepartment of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, India

DOI Number
https://doi.org/ https://doi.org/10.15415/jptrm.2014.22015

Keywords
Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Critical Material Attributes (CMA), Critical Process Parameter (CPP)

Abstract

Quality by design (QbD) is an essential tool in pharmaceutical environment for having product/process/method impregnated with quality. Now, QbD is the greatest solution to construct quality in all pharmaceutical products, while in the same time making it as a part of system is also a key challenge for Industry. For understanding of QbD, it is very much essential to understand the desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). Basically, for meeting the product attributes, the product formulation and process can be designed on the basis of these stated parameters. Nonetheless, this helps in recognizing the effect of raw materials, critical material attributes (CMA), critical process parameters (CPP) on the CQAs and identification and control sources of variability. The in and out understanding for QbD in generic pharmaceutical industry is really vital, because now and then FDA is taking firm stand to make mandatory “deadline” for inclusion of QbD. Therefore, an attempt has been made to highlight quality by design for generic drugs and its implications to pharmaceutical industry.

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How to Cite

Manisha, Swagat Tripathy, Harish Dureja. Panoramic View on Quality by Design. J. Pharm. Technol. Res. Manag.. 2014, 02, 217-231

Panoramic View on Quality by Design

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