The last number of Farmaespaña Industrial publishes our article:
“Ultimas tendencias en la aplicación de Quality by Design: SMART QbD”.
This article describes the methodology SMART QbD which is the result of our 10 years’ experience in QbD practical implementation in more than 20 companies, including drug products and active substances manufacturers.
This article describes the modular methodology that we have developed, based on lessons learned in real projects QbD implementation, and that we have called SMART QbD.
During development, this is about applying the tools efficiently, adapting to the available resources and taking into account the restrictions imposed by the business objectives and “time to market”. Once the product is launched, and during its commercial life, the maintenance of the risk management system is of capital importance.
QbD is the standard in pharmaceutical development, especially for companies whose goal is to sell products in the American market. Even if development was made a few years ago and are currently approved in other countries, it would be convenient to complement it with the QbD approach to fill knowledge gaps and to issue documentation packages that meets FDA evaluators criteria.
For example in this article Backlog unapproved ANDAS the increase in ANDAs time assessment is discussed. Main reason due to the increase in the number of generic products presented and that some of the “pre-selection” criteria is the fulfillment of the quality standards in the information presented:
“A good example is ‘quality by design,’” he said, referring to the agency’s new criteria for good manufacturing processes. “They’d say, ‘Your application isn’t very good because you didn’t have the quality by design concept.”
In conclusion, to avoid delays and questions is it highly advisable to present the information following the scheme of “Question Based Review” which in turn means having introduced the QbD methodology.
For more information please contact us.