Skip to main content
Join CMKC members for a complimentary virtual event on December 10, 11am ET: CM MythBusters: https://bit.ly/3YXJynA. This is a fantastic opportunity to connect, collaborate, and debunk common myths about continuous manufacturing!
18.191.87.157

Tags: Regulatory considerations

Resources (1-1 of 1)

  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...