Saturday, 12 October 2019

Analytical Quality by Design (AQbD): questions and answers


The MHRA has issued a feature on the application of Analytical Quality by Design to pharmacopoeial standards.


Analytical Quality by Design (AQbD) takes a structured approach to the development of analytical procedures which are fit for purpose and that consistently deliver results that meet predefined objectives. It achieves this through a detailed understanding of all aspects of the analytical methods performance ensuring adequate control and an ability to react to changes which can affect the quality of results.

Then review takes the form of a Q&A, which can be accessed here: https://mhrainspectorate.blog.gov.uk/2019/08/21/analytical-quality-by-design-aqbd-questions-and-answers/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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