Author(s): Mitesh D Phale

Email(s): phalemitesh@gmail.com

DOI: Not Available

Address: Mitesh D Phale
Prin. K. M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai- 400 005, India
*Corresponding Author

Published In:   Volume - 2,      Issue - 4,     Year - 2009


ABSTRACT:
The quality of drugs governs by modern analytical tools. The pharmaceutical industry is based around innovation. But rigid regulatory system is unfavorable to innovation. Process Analytical Technology (PAT) emerged as a solution to this. US FDA has introduced PAT for robust and efficient manufacturing in pharmaceutical industry. PAT includes chemical, physical, microbiological, mathematical and risk analysis conducted in an integrated manner. Multivariate tools are used in PAT for design, data acquisition and analysis. With the help of advanced instrumentation, PAT is not only managing to have better manufacturing but also reduces the time, efforts and cost of the process. The sharp features of the PAT enable continuous quality improvement. PAT has the potential to deliver significant shift in the economics of the pharmaceutical sector.


Cite this article:
Mitesh D Phale. PAT: A New Weapon for Pharmaceutical Industry. Research J. Pharm. and Tech.2 (4): Oct.-Dec. 2009; Page 611-616.


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DOI: 10.5958/0974-360X 

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