Abstract

Application of QbD and QbR to Achieve Same Medicine, Same Results with Lower Cost

Barry Gujral, Director, Patheon

The United States (US) spends 17.9 percent of its Gross Domestic Product (GDP) on healthcare as compared to some developing countries like India spending only to the extent of four percent. A major portion of healthcare expense is being spent on pharmaceuticals. There is a challenge to reduce these costs without impacting the quality of healthcare. Generic pharmaceuticals are playing a vital role by producing same medicines, same results but lower costs in order to reduce healthcare expenditure. Currently, it takes a long time for the approval of generic drug. Regulatory agencies took some revolutionary steps to check the backlog of un-reviewed generic drugs applications. The US Food and Drug Administration (FDA) Office of Generic Drugs have developed Question-based Review QbR for the Chemistry, Manufacturing, and Controls (CMC) evaluation of an abbreviated new drug application (ANDA). The QbR system incorporates Quality by Design QbD and implements risk-based assessment. The key achievements of introducing QbD and QbR include: • In-depth understanding of the design, the formula¬tion and the process • Sponsors’ rationale for deci¬sion • Eliminating transcriptional errors • Reducing the review time The QbR and QbD will not only make products and processes more robust but also reduce significantly the health care expenses of both developed and developing countries.