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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

12 April 2016. Pharmaceutical Processing World. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” October 2022.

Health and Personal Care Stores 52
Health and Personal Care Stores Vaccines Packaging Documentation 52
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. BioProcess International 14 (2016): 38–43. Smith, and R.

Documentation 52
Documentation FDA Communication Packaging 52
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