N. Vishal Gupta, S. Prathima, Shashikanth. D, A. Kailash Kumar
Process analytical technologies had been applied to manufacturing processes for decades. Recently, the US Food and Drug Administration (FDA) had re-defined the phrase and implemented into an initiative focusing on improving the several aspects of pharmaceutical industry; European agency for the evaluation of Medicinal products (EMEA) has formed a PAT team in 2003. The PAT initiative was initially intended for traditional pharmaceutical manufacturers, but the FDA’s PAT guidance clearly states that it applies to all manufacturers of human and veterinary drug products, as well as biologics regulated by the center for veterinary medicine (CVM) and FDA’s Center for Drug Evaluation and Research (CDER). Basically, PAT involves testing the quality of the finished drug product, to build the quality into products by testing at several intermediate steps. In this report, the impact and potential effects of PAT on the biotechnological production of pharmaceuticals is assessed and it has been focused on what PAT means in practice for the biotechnological manufacture of pharmaceuticals. It specifically requires quantifiable, casual and predictive relationships, established amongst the initiative for a period of innovation, efficiency and expansion for the biopharmaceutical industry.
