Artificial intelligence in pharmaceutical manufacturing – navigating innovation and regulation
Artificial Intelligence (AI) and Machine Learning (ML) are rapidly transforming various sectors, and the pharmaceutical manufacturing industry is no exception.
This paper explores how the pharmaceutical industry may use individual applications of AI in pharmaceutical manufacturing and control. It describes the evolving regulatory landscape and provides key considerations for national regulatory authorities (NRA) when reviewing regulatory submissions or inspecting manufacturing sites that use or describe AI technologies in their processes.
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