JPTRM Vol. 2 No. 2 (November 2014)

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Panoramic View on Quality by Design
(Chitkara University Publications, 2014-11-30) Manisha; Swagat Tripathy; Harish Dureja
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.