Quality and Regulatory Sourcebook March 2022
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DSCSA's Next Big Hurdle
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BioPharm International's Quality and Regulatory Sourcebook eBook
DSCSA’s Next Big Hurdle
Publication
Article
BioPharm InternationalBioPharm International, Regulatory Sourcebook March 2022
Volume 2022 eBook
Issue 1
Pages: 30-32
Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.
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The 2023 final deadline for full US FDA Drug Supply Chain Security Act (DSCSA) unit level interoperable traceability is looming. By now, most pharmaceutical manufacturers are properly barcoding products to meet current DSCSA-specified labeling requirements for unique product identification at the lot level. The barcodes contain digitized product data that will be used to improve patient safety by enabling major improvements in the track-and-traceability of drugs as they move through the supply chain.
Now it’s time for companies to begin exchanging the necessary data to ensure readiness for November 2023. Establishing interoperability between all stakeholders up and down the supply chain is a complex undertaking—it will take every bit of time that remains before the deadline.
Read this article in BioPharm International's March 2022 Quality and Regulatory Sourcebook eBook.
About the author
Tracy Nasarenko is senior director Community Engagement, GS1 US.
Article Details
BioPharm International eBook: Quality and Regulatory Sourcebook, March 2022 Pages: 30-32
Citation
When referring to this article, please cite it as T. Nasarenko, “DSCSA's Next Big Hurdle," BioPharm International Quality and Regulatory Sourcebook eBook (March 2022).
Articles in this issue
In-Use Testing of Cleanroom Garments
How a Lack of Critical Thinking is Hindering Regulatory Compliance
Contextualizing Computer Validation
Assessing the Quality of CAR-T Cells Using ddPCR
The Data Relationship
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
A New Route to Pharma GDP Compliance and Standardization
Remote Inspections - Lessons Learned
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