Masters Thesis

Evaluation of a quality by design approach to addressing drug shortages in generic injectable pharmaceutical products

Drug shortages, particularly generic sterile-injectable formulations, present a serious problem to manufacturers, regulators, prescribers, and patients in the United States. Sources, including FDA warning letters, industry publications, and industry experts are examined to determine potential causes of drug shortages and see if they might be reduced or prevented via Quality by Design (QbD) implementation by drug manufacturers. QbD is researched using published work by Juran, journal articles, and recent industry guidelines such as the International Conference on Harmonization (ICH) Q8 and the FDA’s question-based review for Abbreviated New Drug Applications (ANDAs); from here, QbD is broken down into critical elements and each is linked to potential benefits. Product and process problems linked to potential drug shortages are analyzed with respect to benefits expected from QbD implementation. Research shows QbD implementation can be expected to prevent many though not all, generic sterileinjectable drug shortages.