QbD's Role in Pharmaceutical Solid Dose Dry GranulationSource: Gerteis Maschinen + Processengineering AG
The Pharmaceutical industry is undergoing change. Under fire by political pressures to drive down the cost per tablet, compounded by new drug discovery becoming more challenging escalating research costs, therefore, the industry is looking to unleash its efficiency shackles of the past. With both the regulators, such as the FDA, recognizing change is needed and an increase in demand for low cost essential drugs from new growth markets and developing nations provides an opportunity to capitalize on efficiency gains with the right technologies.
The industry is steeped in a history of batch based manufacturing unlike other sectors such as food and bulk chemicals. This is to give the accountability and traceability required to ensure drug safety to the public.