Pharmaceutical Serialization Playbook

Topics covered

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
• How GS1 can 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

Bonus

Exclusive results of Healthcare Packaging serialization readiness survey. Find out how far ahead (or behind) you are compared to the industry as a whole!
 

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."