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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

Although the novelty of these modes of manufacturing has led to some definitional ambiguities, initial working definitions and terminology have been drafted by several regulators, trade organizations, and subject matter experts. Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” 16 June 2020.

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. IDMP Definition of Identification of Medicinal Products.”

Documentation 52
Documentation FDA Communication Packaging 52
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