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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. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” New Project: Evolutive Vaccines Facility for Sanofi.”

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. Health authorities have divergent classifications for changes in terms of risk to product quality and documentation/data requirements. Burke, PhD. 1 September 2022.

Documentation 52
Documentation FDA Packaging Communication 52
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