Quality by Design

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

More informed submissions may lead to regulatory flexibility for postapproval changes.

The International Conference on Harmonization has released an Annex to its Q8 guideline, Pharmaceutical Development.

Design space concepts are key to a successful technology transfer.

How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step.

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007.

Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space.