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Tags: Quality assurance.

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  1. Quality & Regulatory Solutions for PAT in Continuous Manufacturing

    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. 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

  3. 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

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

    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...

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

    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...