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QbA -> QbD: An imaginationand creativity challenge

EPCOT International, 29150 Bryce Road, Pepper Pike, OH 44124, USA

This article in brief discusses opportunities we have to makeQbD (quality by design) as a way of life in the manufactureof active pharmaceutical ingredients (API). APIs are simplyfine and specialty chemicals that have a disease curing value.Chemists and chemical engineers routinely develop andcommercialize processes for such chemicals that are:
  • Economical
  • Safe
  • Sustainable
  • Produce repeatable quality product
However, the above, except for safe, does not happen for APIsdue to the limitations of equipment used, the yearly productvolume and our ability to achieve the desired profit margins.In API manufacturing QbA (quality by analysis) has become thetradition to ensure product quality.Table 1 shows the volume of API needed (at 80 percentformulation yield) for products at two different average wholesaleprice (AWP) levels for the blockbuster drugs. ...