Abstract

Pharmaceutical industry has been always emphasizing on product quality, efficacy and safety. Now a day’s the process automation also being considered which heading Pharmaceutical Industry. The traditional quality by testing (QbT) approach was being followed in older days. The product quality and performance are predominantly ensured by end product testing, with limited knowledge of the product, process and critical process parameters. Recently these quality, safety & efficacy of the products are the prime requirements, thus the Regulatory bodies are focusing on implementing quality by design (QbD) and Process analytical tools (PAT), which are the science based approach for better products and 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 Research and Development (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 automation in the pharmaceutical process.

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