Resources (1-3 of 3)

1. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

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   Magazine | 04 Jan 2024 | 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...

2. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

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   Document | 09 Jun 2023

   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...

3. A brief review on Process Analytical Technology (PAT)

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   Peer-reviewed journal | 09 Jun 2023 | 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...