Pharmaceutical Serialization Playbook

Download this free e-book, updated for 2015 with the latest serialization success strategies.

With the passage of the Drug Quality and Security Act of 2013 (DQSA), everything you thought you knew about serialization has changed. Is your company ready? Download this free e-book, updated for 2015, with the latest serialization success strategies, real-world implementation tips, and pitfalls to avoid.

A detailed timeline lets you know what’s changing, and how soon. 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.

Experts

Sourced in this e-book
Bill Fletcher
Managing Partner
Pharma Logic Solutions
Dirk Rodgers
President
RxTrace
Robert Celeste
Director, Healthcare
GS1 US
Sean Mulholland
Senior Quality Compliance Officer
Almac Pharma Services
Greg Cathcart
CEO
Excellis Health Solutions
Dave Mason
Packaging Engineering Consultant
Neville Noel
Managing Partner
Endeavor Consulting Group
Stephen McIndoe
Vice President, Consulting
Be4ward
Jim John
Project Management Quality Consultant
ProPharma Group
Elliot Abreu
Senior Vice President
Xyntek-Antares
Jean-Pierre Allard
Serialization Product Manager
Optel Vision

Topics covered

The new U.S. law

  • Drug Quality and Security Act of 2013
  • Key concepts of the U.S. federal law
  • The timing of the U.S. federal law
  • Serialization around the world
  • Global compliance: Flexibility is the key

Staffing & project management

  • Building a proper serialization team
  • Secrets to serialization project management
  • 11 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
  • Nine coding/marking considerations for serialization
  • Vision system considerations
  • Label and panel redesign considerations
  • Impact on production line speeds and OEE
  • Impact on production/operations workflows

The supply chain: Beyond the four walls

  • Transaction models and the U.S. drug supply chain
  • Transaction implications of the four views
  • Minimizing the complexity of connections
  • Impact on wholesaler/distributors, pharmacies, clinics, and hospitals
  • Contract manufacturing & packaging strategic considerations
  • Five implementation tips for CMO/CPO’s
  • 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 transaction 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

Downloads

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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