Considerations for a Decentralized Manufacturing Paradigm
ISPE
SEPTEMBER 11, 2023
www.fda.gov/media/162157/download 7 Okwudire, C. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” www.raps.org/news-and-articles/news-articles/2023/3/fda-official-warns-manufacturers-of-common-problem 25 US Food and Drug Administration Center for Drug Evaluation and Research. Discussion paper.
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