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Tags: Validation

Peer-reviewed journal (1-2 of 2)

  1. Regulatory and Quality Considerations for Continuous Manufacturing

    09 Jun 2023 | Contributor(s):: Allison, Gretchen, Cain, Yanxi Tan, Cooney, Charles, Garcia, Tom, Bizjak, Tara Gooen, Holte, Oyvind, Jagota, Nirdosh, Komas, Bekki, Korakianiti, Evdokia, Kourti, Dora, Madurawe, Rapti, Morefield, Elaine, Montgomery, Frank, Randolph, William, Robert, Jean-Louis, Rudd, Dave, Nasr, Moheb, Zezza, Diane

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including...

  2. Near Infrared Method Development for a Continuous Manufacturing Blending Process

    09 Jun 2023 | Contributor(s):: Colon, Yleana, Florian, Miguel, Acevedo, David, Mendez, Rafael, Romañach, Rodolfo

    Purpose This study describes the validation of a near infrared spectroscopic method for monitoring a continuous manufacturing system. The achievement of this goal requires determining the near infrared (NIR) method’s accuracy, precision, obtaining an estimate of the sample volume analyzed, and...