Modern Pharmaceutical Regulations: Quality Assessment for Drug Products

Abstract Information on the chemistry, manufacturing, and controls (CMC) for the drug product must be submitted to the Food and Drug Administration (FDA) to support the approval of original new drug applications (NDAs) and abbreviated new drug applications (ANDAs). This chapter discusses assessment of the CMC information for drug products with a focus on question-based review (QbR). The QbR is structured to facilitate the assessment of applications submitted in the International Conference on Harmonization (ICH) common technical document (CTD) format. Although QbR was initially introduced for drug products submitted in ANDAs, its principles apply equally well to drug products submitted in NDAs.