Why Industry-Wide Standards Matter In Fulfilling the Intent of DSCSA

Christiane Wirrig, PhD ,
Christiane Wirrig, PhD
David Kessler
David Kessler

Published: 03.12.2023.

Biochemistry

Volume 6, Issue 2 (2023)

https://doi.org/10.30953/bhty.v6.293

Abstract

Speakers discuss the importance of standardization in order to digitalize the U.S. pharmaceutical supply chain as motivated by the Drug Supply Chain Security Act (DSCSA). Key topics What is DSCSA? What does FDA’s Stabilization Period mean? Why do technology standards matter and how are they being implemented, i.e. interoperability through standards? Focus on standardization, due diligence in the context of DSCSA-regulated digitally managed pharma supply chain 2023 readiness in relation to stabilization period until 2024 Inspections will keep happening ATP is mandatory, authentication & authorization Data security

Keywords

Citation

Copyright

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 

Article metrics

Google scholar: See link

The statements, opinions and data contained in the journal are solely those of the individual authors and contributors and not of the publisher and the editor(s). We stay neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Most read articles