05 Dec 2013, BioSpectrum Bureau , BioSpectrum
Singapore: As Asia emerges as a major engine of global economic growth, the pharmaceutical and biotechnology industries in the region are expected to experience intensified competition and regional pharmaceutical sales are expected to hit USD386 billion, reflecting an annual average growth rate of more than 13 percent, according to a report by Economist Intelligence Unit (EIU).
The incorporation of Quality by Design (QbD) in the manufacturing process will help propel regional manufacturers to achieve quality and cost effectiveness to successfully compete in this growing market. Mr. Valentino Dhiyu, Formulator, Invida noted, "Product and process development account for 15-30 percent of overall R&D expenditure. Based on the experience of some companies, organisations that embrace QbD can significantly reduce costs, improve products, shorten time to launch, reduce risk, and improve patient benefits."
CPhI, Quality by Design is a three-day technical event from 24-26 February 2014 in Kuala Lumpur, Malaysia that includes an exclusive two-day workshop, "Quality by Design Implementation Roadmap Masterclass". The event will address business drivers, regulatory frameworks, risks, principles and approach for QbD by speakers from both regulators and manufacturers such as the Food and Drug Administration, Philippines, Biocon and Invida.
Mr. Nitin Madhukar Kadam, Assistant Manager R&D (Formulation), Medica Pharmaceutical Industries commented, "Asia has a huge landscape to grow and implement the QbD concept because the new era of approaches to quality has just began to harmonise global quality pharmaceuticals." CPhI, Quality by Design is an opportunity for those in the pharmaceutical research and development, formulation, analytical, regulatory affairs and quality areas to explore and integrate QbD to in their organisations and building quality into product development.