ISSN : 2348 - 8948

Current Issue

Volume : 5 Issue :9 Month : September (2017)
Page Numbers : 369-375

The significance of collective role of QbD and PAT Tools in the Pharmaceutical Process Automation

Parag Das
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.
 
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