The pharmaceutical industry is in rapid transition from a supply-driven market to a demand and service-driven market where manufacturing efficiency and responsiveness will play a critical role in future success. Pharmaceutical manufacturers generously allocate funds to research and marketing, but they as a whole lags behind other automated industries in one key aspect: manufacturing quality analysis. To overcome this there is growing enthusiasm in the industry for the many potential gains offered by process analytical technology, a new FDA initiative that aims to foster improvements in manufacturing efficiency and quality analysis. Pharma Industry is facing growing demands for increased productivity and reduced manufacturing costs and also has to meet the evolving need for higher quality standards and higher drug expectations The regulatory area appears to be rapidly evolving, with PAT initiative to be the first major change in the GMP's in over 25 years that is based on increased scientific understanding and less on an empirical based approach. The underlying premise of process analytical technology is that quality cannot be tested into products; instead it should be built-in or should be by design. Along with benefits there are numerous technical, cultural, organization and regulatory hurdles on the PAT path.
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