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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. September 2004. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” September 2004.

Health and Personal Care Stores 52
Health and Personal Care Stores Vaccines Packaging Documentation 52
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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. 6 US Food and Drug Administration. Burke, S., Hammond, and T.

Documentation 52
Documentation FDA Packaging Communication 52
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