Epedigree in the Pharmaceutical Supply Chain - Pharmaceutical Technology

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Epedigree in the Pharmaceutical Supply Chain
The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.


Pharmaceutical Technology


Other solutions

Specialized vendors are offering applications to assist in meeting ePedigree and supply-chain requirements. For example, SupplyScape (Woburn, MA) introduced in June 2008 Nexus-enabled applications and services to its product serialization and supply-chain optimization solutions. Nexus is a network-based data-sharing and collaboration platform to facilitate interoperability within trading networks.

Axway (Scottsdale, AZ) offers its "Synchrony" supply chain integrity suite as a solution for supply-chain management among life-science companies and its trading partners. The product includes capabilities for data-integrity assurance, ePedigree, business-activity monitoring, and trade- activity management, and track-and-trace functionality.

In July 2008, rfXcel (San Ramon, CA) release its "Everest" track-and-trace platform for ePedigree and serialization compliance and business analytics. In January 2008, Acsis (Marlton, NJ) released "PharmaTrak 2.0," a preconfigured, serialized track-and-trace solution developed for pharmaceutical manufacturers, co-manufacturers, and distributors The software is designed to manage serialized drug products in warehouse and distribution centers to support the ability to generate ePedigree documents, automate product movement and transfers, as well as support track, trace, and product authentication through the supply chain.

References

1. FDA, "Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments" (Docket No. FDA-2008-N-0120), Fed. Reg. 73 (55), 14988–14991, Mar. 20, 2008.

2. FDA, "Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information" (Docket No. FDA-2008-N-0121), Fed. Reg. 73 (55), 14991–14992, Mar. 20, 2008.

3. California State Board of Pharmacy, "Response of the California State Board of Pharmacy, Docket No. FDA-2008-N-0120, Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments" (Sacramento, CA, May 12, 2008), available at http:// http://www.pharmacy.ca.gov/laws_regs/docket_0120_comments.pdf, accessed Aug. 4, 2008.

4. California State Board of Pharmacy, "Response of the California State Board of Pharmacy, Docket No. FDA-2008-N-0121 Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information" (Sacramento, CA, May 12, 2008), available at http:// http://www.pharmacy.ca.gov/laws_regs/docket_0121_comments.pdf, accessed Aug. 4, 2008.

5. P. Faber, "RFID Strategy—Pharmaceutical EPedigree—Biggest Supply Chain Topic of 2008," Industry Week, Jan. 21, 2008.

6. M. Rose, "Testimony before the Senate Judiciary Committee" (Washington, DC, June 17, 2008), available at http://judiciary.senate.gov/pdf/08-06-17Mike_Rose_Testimony.pdf, accessed Aug. 4, 2008.

7. P. Spellman, "EPedigree to the Next Degree," Pharm. Exec. 28 (3), 32–34 2008.

8. G. Koroneos, "Congress to Consider National ePedigree Standards," Pharm. Exec. (online), Apr. 30, 2008, available at http:// http://pharmexec.findpharma.com/pharmexec/News/Congress-to-Consider-National-ePedigree-Standard/ArticleStandard/Article/detail/512999, accessed Aug. 4, 2008.

9. House Committee on Energy and Commerce, "Revised Discussion Draft of the Food and Drug Administration Globalization Act of 2008" (Washington, DC, July 24, 2008), available at http://energycommerce.house.gov/FDAGlobalAct-08/RevisedFDAGA.DraftDrugSafetyTitle.072908xml.pdf, accessed Aug. 4, 2008.


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