The significance of collective role of QbD and PAT Tools in the Pharmaceu-tical Process Automation

Abstract

Pharmaceutical industry has always been striving  on product Quality, Efficacy and safety and now one step ahead the process automation also under transformation. However at past these attributes were not so much focused or mandatory. In earlier days the traditional quality by testing (QbT) approach was being followed, the product quality and performance are predominantly ensured by end product testing, with limited understanding of the product, process and critical process parameters understanding. In recent days these quality, safety & efficacy of the products are the prime focus, thus the  Regulatory bodies are  emphasizing  on implementing quality by design (QbD) and Process analytical tools (PAT)  , the  science based approach for better  products &  process understanding by reducing process variation and the enabling process-control strategies. In this regards, pharmaceutical industry is currently undergoing a significant transformation to streamline their R&D process, provide greater manufacturing flexibility and control, and to reduce regulatory burden. However, till date there is limited understanding and major concerns regarding the implementation of QbD principles and PAT in the pharmaceutical arena. The objective of this article is therefore to provide a comprehensive understanding on various aspects of QbD and PAT, along with addressing the concerns related to its implementation to achieve the pharmaceutical process automation.