As the pharmaceutical industry reimagines manufacturing paradigms with new decentralized and variable approaches, it is important to engage with authorities on how to adapt existing regulatory schemes, Christine Moore, Organon, told the recent 2022 CASSS WCBP biopharmaceuticals characterization conference.
Industry Urged To Share Potential Regulatory Challenges To Decentralized Manufacturing
In a world where pharmaceuticals could be manufactured with no fixed address, industry and regulatory authorities must work together to interpret site-based compliance requirements, expert says. New concepts like the MHRA-proposed hub-and-spokes model could play key role.
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