With compliance dates for the Drug Supply Chain Security Act (DSCSA) approaching, pharmaceutical manufacturers and packaging/labeling professionals need to make important decisions, reports Salil Joshi, Senior Director, Industry Development – Healthcare, GS1 US. These decisions include “selection of serialization technology and selection of method for exchange of transaction level data,” he tells PMP News.
Joshi (pictured at right) will be speaking at the upcoming Pharmapack North America conference on June 10 during “Pharmaceutical Serialization Standards, Guidances, & Best Practices” at 1:35 pm. He will provide overview of the DSCSA timeline, guidance on how to effectively manage serialization requirements for manufacturers leveraging GS1 Standards, and best practices for exchanging transaction data between supply-chain trading partners.
Packaging professionals do continue to face major challenges, acknowledges Joshi, including:
- Understanding of requirements for compliance and timelines associated with it.
- Costs involved with serialization.
- Selection of the right technology that fits the individual organization’s needs.
“After hearing the presentation, we hope attendees will have a better understanding of DSCSA requirements and also create a strategy and implementation plan for serialization,” Joshi says. “This strategy can include selection of system provider who can assist with compliance with DSCSA and the selection of a framework for exchanging Transaction Information, Transaction History, and Transaction Statement with the distributors. Because GS1 US also has a number of educational resources via webinars and workshops, we hope that attendees will continue to turn to GS1 US for assistance.”
For instance, the mission of the GS1 Pharmacy Secure Supply Chain workgroup is to support pharmaceutical supply-chain members in their efforts to use GS1 Standards for business and regulatory purposes,” Joshi says. “The current focus of the group is to provide guidance on how to use GS1 Standards to address requirements of the Drug Supply Chain Security Act (DSCSA).”
In addition, the Electronic Product Code Information Services (EPCIS) standard, developed by GS1, has been listed as one of the methods for exchanging data between supply chain partners in the FDA’s guidance for the industry for exchanging product tracing information, Joshi reports.
Other Pharmapack North America presentations with speakers discussing the pharmaceutical supply chain on June 10 include the following:
"Mitigate the Risk of Counterfeiting to Your Brand, Trading Partners, and Patients"
Want to beat counterfeiters? Understand how pharmaceutical counterfeiters operate and infiltrate legitimate supply chains and what you can do with process and technology to detect, deter, and disrupt their efforts.
Tim Marsh, Managing Director, SUPPLY CHAIN SECURITY PARTNERS
Brian Donnelly, Global Security, Director, Americas Region, PFIZER
"Pharmaceutical Serialization: From Master Data to “In-spec” GS1 Data Matrix Symbols – Essential Elements and Common Pitfalls"
To successfully implement item, bundle, and case-level serialization and 2-D bar code marking in the global pharmaceutical supply chain, you must discern and document the processes that reliably transform master data into “in-spec” GS1 DataMatrix symbols. This session will provide the necessary insights to help ensure repeatable, successful implementations at all levels of packaging, across multiple platforms, lines, or contract manufacturing organizations.
George Wright, Vice-President, Consulting & Business Development, PRODUCT IDENTIFICATION & PROCESSING SYSTEMS INC.
"Creative Packaging Designs for Drug Serialization"
You’re going to need some help to manage serialization from start to finish. Learn how creative packaging designs and enterprise systems can help you comply with the latest serialization and traceability regulations in life sciences. Hear lessons learned from an expert who has helped more than 25 leading drug manufacturers, distributors and third-party logistics providers.
William Fletcher, Managing Partner, PHARMA LOGIC SOLUTIONS LLC
"The Sanofi Serialization Program"
Hear about Sanofi Pasteur’s program, including the approach, the impact, and the best practices, directly from the serialization program’s leader who has been managing the continued development of the Antares Serialization core model application.
John Woodburn, North America Regional Project Leader, SANOFI PASTEUR
Adriano Fusco, Global Marketing Manager, ANTARES VISION
Visit www.pharmapacknorthamerica.com to register today.