Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form

By Joe Cobb, R. Justin Brett, Michael D. Ruff, Anthony Berry, Robert Epps

As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”¹ Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”² that includes ideas such as Quality by Design (QbD) in the development process.  This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.