Remove Definition Remove Process Improvement Remove Vaccines
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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

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.”