Acta Scientific Pharmaceutical Sciences

EditorialVolume 2 Issue 4

Quality by Design: An Interface between Effort and Success

Anuradha Sharma* and Abhinav Mankoo

Faculty of Pharmaceutical Sciences, Punjab College of Technical Education Group of Institutes, Baddowal, Ludhiana, India

*Corresponding Author: Anuradha Sharma, Faculty of Pharmaceutical Sciences, Punjab College of Technical Education Group of Institutes, Baddowal, Ludhiana, India.

Received: February 28, 2018; Published: March 01, 2018

Citation: Anuradha Sharma and Abhinav Mankoo. “Quality by Design: An Interface between Effort and Success”. Acta Scientific Pharmaceutical Sciences 2.4 (2018).

  While designing a formulation the major concern of a formulator is to achieve the best degree of quality in the final product. Before FDA launched Current Good Manufacturing Practices, the quality of a product was only defined using the quality control tests or more specifically Quality by Test (QbT). In case of pharmaceuticals, the product is defined on the basis of its quality. So, the quality of pharmaceutical product should be determined by a more effective and a comparably easy method. For this, FDA generalized the con- cept of Quality by Design (QbD), which was based on the conceptual understanding of how the attributes of a production process or the attributes of the material used in the specific process affecting the quality of the end product that is the final required product. The application of Quality by Design (QbD) in pharmaceutical drug development loop is now a thrust area for the regulatory authorities as well as the industry views

Copyright: © 2018 Anuradha Sharma and Abhinav Mankoo. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



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