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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
| Contributor(s):: Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
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Uchenna Anunike
Wields the knowledge and experiences of Good Manufacturing Practices (GMP) and Good Laboratory Practice (GLP) in striving for excellence, fostering creative ways to enhance managerial drive and...
https://cmkc.usp.org/members/1670
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Kirti Narsai
Kirti has 25 years’ experience in the healthcare industry and held board positions in several large organisations with Pan African interests & was a member of the African Regional...
https://cmkc.usp.org/members/1149
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Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has...
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A brief review on Process Analytical Technology (PAT)
| Contributor(s):: Mali, Akash, Jagtap, Monali, Karekar, P., Maruska, A
Process analytical technology (PAT) has been defined as a mechanism to design, analyze and control pharmaceutical manufacturing processes through measurement of critical process parameters which affect critical quality attributes. PAT checks the quality of raw material attributes both physically...