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2D Vaccine Barcoding - For Manufacturers

Vaccine manufacturers play a key role in affixing 2D barcodes on vaccine vials and syringes. The following information about 2D barcoded vaccines provides the resources for guidance on requirements and general specifications to date. Also provided are the vaccine manufacturers forum's presentations and summary documents that discuss the implications, opportunities, and challenges of implementing 2D barcoding technology on vaccine products.

 

2D Barcoding Resources

 

Impact of 2D Barcodes on Vaccine Secondary Packaging Report

This report evaluates the impact of 2D barcodes on vaccine secondary packaging. Typically, the information from the vaccine secondary packages is used to record inventory information. This includes a listing of benefits and challenges at different points in the vaccine supply chain from manufacturer to distributor to provider to IIS.

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Vaccine Manufacturer's Forum

On January 26, 2012 CDC held a 2D Barcode Vaccine Manufacturers Forum to engage the vaccine manufacturing community.  It included vaccine product manufacturers, their distributors, and trading partners in presentations and discussions on the implications, opportunities, and challenges of implementing 2D barcoding technology on vaccine products.

The goals and objectives of the Forum were to:

  • engage the vaccine manufacturing community in the discussion of the benefits, impacts, and challenges of implementing 2D barcoding,
  • understand the regulations and standards landscape in more detail, and
  • explore the options and considerations for moving the industry forward toward the implementation of 2D barcoding of vaccine products.
Speakers discussed implementation issues and standards related to 2D barcoding technology for vaccine products. A working session during the forum divided attendees into smaller groups to discuss topics related to opportunities and challenges regarding 2D barcode implementation.

Forum Attendees

It was attended by over 60 industry stakeholders including 26 representatives from 10 vaccine manufacturing companies, representing functions of packaging, distribution, policy, regulatory affairs, technical services, customer service, and new products. In addition to the manufacturers, the Forum was attended by representatives of retail pharmacy supply chain participants, standards organizations, and trade associations. Regulatory and global agencies including World Health Organization (WHO), the Food and Drug Administration (FDA), and CDC participated in the event, providing a rare opportunity for the industry and regulators to connect and discuss the changing requirements and standards for vaccines.

Forum Presentations

Presenter Presentation
Anne Schuchat, MD
Director, CDC/National Center for Immunization and Respiratory Diseases (NICRD)
Opening Remarks[3 pages]
Erin Kennedy, DVM, MPH
Medical Officer, CDC/NCIRD
Overview of 2D Vaccine Barcoding Pilot[28 pages]
Vada Perkins, BSN, MSc, RN
Chief, Business Operations Staff, US Food and Drug Administration (FDA)
Overview and Guidance on Vaccine 2D Barcoding[26 pages]
Edward Zissman, MD, FAAP
American Academy of Pediatrics (AAP)
Industry Goals and Progress for Vaccine Barcoding - Perspective from AAP[1.2 MB, 26 pages]
Alan O'Connor, MBA
Senior Economist, Research Triangle Institute (RTI)
Overview of Vaccine Bar Coding Report[34 pages]
John J. Roberts, JD
Director, Healthcare, GS1 US
Emerging Standards for Vaccine Barcoding - GS Overview[2.1 MB, 35 pages]
Bonni Kirkwood
Senior Manager, Deloitte Consulting LLP
Overview of Working Sessions[18 pages]

Forum Summary Documents

 

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