IJFANS International Journal of Food and Nutritional Sciences

ISSN PRINT 2319 1775 Online 2320-7876

A Bird’s Eye View On Quality By Design (Qbd) Approach: Analytical Method Validation

Main Article Content

Patel Seema A, Sayyed Nazifa S, Manjra Mehfuza U, Lajporiya Mobina I, Aejaz Ahmed, Khan G. J

Abstract

Quality-by-design (QbD) is a systematic approach to drug development, which commence with clear objectives. Its uses science and risk management approaches to gain product and process understanding and finally process control. The idea of QbD can be extended to analytical methods. New drug development must implement Quality by Design approach. Most of regulatory agencies and or FDA are reviewing the drug development data. To answer such agencies and FDA one has to go towards a more scientific, risk based, holistic and practical approach. The emphasis of Analytical QbD approach is on understanding of the operation and the variables affecting Analytical Methods employed in product development and hence creating an extensive knowledge repository. The variables which affect the outcome are recognized and subjected to methodical risk assessment employing a variety of tools and practice discussed in the article, after which the variables are optimized. The end method is validated and a control strategy is set in a position. The main objective of the present review article to describe different steps involved in method validation by QbD approach for an analytical method development and validation.

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