'Quality by Design' (QbD) is one of a series of programs that the FDA includes in their 'Quality in the 21st Century' initiative. In summary, this program emphasizes the fact that quality cannot be tested into anything, it has to be built in. In this particular instance the built-in quality is the understanding of the formulation and process. The built-in limits assure that the finished medicinal product will consistently deliver the drug in the correct amount, at the correct rate, over the shelf-life of the product.
In practice, if one is able to establish the 'Design Space' for the product, there may be significant post approval regulatory savings in terms of supplemental filings. When executed properly, QbD is the foundation for robust medicinal products and Process Analytical Technologies (PAT).
Much of the work associated with QbD and determination of the design space will be carried out as part of the process optimization and scale-up. This will build on the studies already carried out as part of the formulation and process design phase. Some work will also necessarily be carried out at full commercial scale.
FinnBrit Consulting has the knowledge and experience to advise clients on how to implement an effective Quality by Design strategy.
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