The requirements for track-and-trace are relatively new, and new aspects of them are continually coming into force all around the world. It’s a constantly moving target that drugmakers need to be able to hit no matter where their supply chain takes them.
But it’s a vast — and expensive — undertaking that can take months or even years to implement. The idea is that a drugmaker should be able to track a product’s development journey, documenting each supplier transaction and transferral so that any problem can be traced to the exact point at which things started to go wrong.
Drugmakers that embrace the challenge will find that there are benefits and opportunities that make up for the cost and complexity of the effort.
This management report looks at the status of developing regulations in the US and around the world — e.g., the EU, Turkey, India, China, Brazil, Argentina and Korea — and explains what drugmakers must do to meet upcoming compliance deadlines. Readers will learn how to meet the challenges of implementing a global supply chain security system and how to balance risks with the opportunities a well-crafted system can present.
Old technology vs. new: how your supply chain needs to transform for compliance
How to create a timeline for developing a global system
Six steps to achieving a cost-effective system
The biggest myths and misconceptions about track-and-trace
U.S. requirements and timeline compared to the rest of the world
How to recognize and take advantage of opportunities presented by global serialization
PDF Edition — $397
Table of Contents
The Global Drug Serialization Movement
Serialization, Track and Trace in the U.S.
Serialization Efforts in the EU and Around the World
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.