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Authors
Affiliations
1 Department of Pharmaceutical and Medicinal Chemistry, Shri Sarvajanik Pharmacy College, Gujarat Technological University, Arvind Baug, Mehsana-384001, Gujarat, IN
2 Maliba Pharmacy College, Bardoli-Mahuva Road, Gopal Vidyanagar, Ta. Mahuva, Dist.-Surat, Pin-394 350, IN
Source
Research Journal of Science and Technology, Vol 2, No 6 (2010), Pagination: 129-133
Abstract
Process analytical technology is one of the objectives contained in the Initiative for Pharmaceutical cGMPs for the 21st Century published by the Food and Drug Administration as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters which affect Critical Quality Attributes. As a direct consequence of the "cGMPs for the 21st Century" initiative, FDA released its PAT initiative; few pharmaceutical companies are willing to talk about their efforts to implement PAT. To encourage industry for PAT implementation FDA introduced the "safe harbor" or "research exemption" concept which is designed to encourage the industry to investigate tools that will provide increased process information without the fear of having a negative impact on the ability to release products that meet all aspects of the company's current quality control strategy. PAT focuses on the use of in-line testing using various tools like near infrared, Raman, or other physiochemical techniques as a primary means of process monitoring. PAT tools and its applications like Near Infrared Spectroscopy and Raman Spectroscopy in powder blending. Use of PAT in process development by implementation of NIR, Attenuated Total Reflectance-Fourier Transform Infrared (ATR-FTIR), Raman and Focused Beam Reflectance (FBRM).
