Pharmaceutical Serialization Playbook

Download this free e-book, updated for 2014 with the latest serialization success strategies.

New federal legislation has passed, rendering state e-pedigree mandates, such as California’s, obsolete. Now what? This incredibly useful guide from the editors of Healthcare Packaging magazine has been substantially updated with the latest on the changes surrounding serialization. Easy-to-comprehend segments cover everything from assembling your serialization team, to pilot testing and more.

Written for the entire serialization team, from packaging through IT, this Playbook is jam-packed with hands-on, actionable advice from those who’ve been there. With extensive input from GS1, you’ll be up-to-date on standards and how the new legislation will change the serialization landscape.


Sourced in this e-book
Dirk Rodgers
Bill Fletcher
Managing Partner
Pharma Logic Solutions
Robert Celeste
Director, Healthcare
Sean Mulholland
Senior Quality Compliance Officer
Almac Pharma Services
Greg Cathcart
Excellis Health Solutions
Michael Stewart
Strategic Business Planning, Track and Trace Projects
PharmTech, Inc.
Dave Mason
Packaging Engineering Consultant
Neville Noel
Managing Partner
Endeavor Consulting Group
Stephen McIndoe
Vice President, Consulting
Jim John
Project Management Quality Consultant
ProPharma Group
Elliot Abreu
Senior Vice President
Jean-Pierre Allard
Serialization Product Manager
Optel Vision

Topics covered

How we got here

  • Impact of new federal Drug Quality & Security Act (DQSA) legislation
  • How and when it will go into effect
  • Business case for serialization
  • Are all of your company’s efforts to date wasted?
  • What about partial containers?

Staffing & project management

  • Building a proper serialization team
  • Secrets to serialization project management
  • 10 steps to get started with serialization
  • 11 routinely underestimated aspects of serialization

Line and plant strategies

  • Packaging line modifications for serialization
  • What “inference” is and why it matters
  • Strategies for accurate aggregation
  • Eight coding/marking considerations for serialization
  • Vision system considerations
  • Label and panel redesign considerations
  • Impact on production line speeds and OEE
  • Validation considerations for serialization
  • Impact on production/operations workflows

The supply chain: Beyond the four walls

  • E-pedigree models and the U.S. drug supply chain
  • Impact on wholesaler/distributors and pharmacies
  • Contract manufacturing & packaging strategic considerations
  • Five implementation tips for CMO/CPO’s
  • Case study: Contract packager builds its own serialization solution
  • Questions to ask your CMO/CPO about serialization

Software & Architecture

  • Line and plant level software implications
  • Avoid these EPCIS interoperability pitfalls
  • Issues with master data
  • How to avoid the leading zero issue
  • Preventing counterfeit e-pedigree data

Pilot testing guide

  • Determining goals and metrics for pilot testing
  • Getting started with pilot testing
  • Pre-flighting your supply chain pilot
  • Lessons learned: project and vendor management
  • Lessons learned: on the packaging line
  • New GS1 help with pilots
  • Mixing serialized with non-serialized shipments


Downloadable Word document with actual language to help you get started with your project:

  • Sample user requirements starter document

 Plus: Vendor Selection Resource Guide

  • Questions to ask serialization solution providers
  • Detailed profiles of vendors who can help implement your serialization program

Praise from early reviewers for Healthcare Packaging’s Pharmaceutical Serialization Playbook:

"You did a great job capturing the essence of what people need to know."

"I just wanted to pause to tell you that you have created an incredibly useful and usable document that will help people come up to speed quickly and avoid the same mistakes that the pioneers made."

"Very well written."

"I’ve read through the playbook and everything looks great. Great work by you and your team."

"I think this is going to be an amazing source of information for the pharma industry.  Great job!"

"Great information and I know we will be using this as a guideline to a successful serialization implementation.  I sent this playbook to some team members and they thought this was "EXCELLENT" and a "WELL DONE DOCUMENT"!  Hope others see the value as we do.  Thanks for all your efforts and keeping me in the know."

"The playbook is excellent. I’d imagine this will serve as a critical document for the industry."

"I am pleased with the content of the playbook. Your team did an excellent job putting this content together."

This playbook is proudly sponsored by:
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Vision system
Coding/ marking/ printing
Labeling equipment
Serialization line/ plant solution
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Case packing equipment
Shrink bundling equipment
Other packaging equipment
Bar code scanners/ readers
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