- September 23, 2013
By Bill Lydon, Editor
As government agencies and the pharmaceutical & life sciences industry take measures to reduce drug counterfeiting, product diversion, and increase patient safety, drug manufacturers are faced with the challenge of implementing serialization and tracking systems.
Pharmaceutical Automation Roundtable (PAR) 2012 – Part 7
By Bill Lydon, Editor
This is the seventh article of a series about the annual Pharmaceutical Automation Roundtable (PAR). I attended the Roundtable in November 2012, hosted by AbbVie, which at the time was part of Abbott in North Chicago, Illinois. Lead automation engineers from pharmaceutical companies all around the world participated. The PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies. This is the most knowledgeable group of pharmaceutical automation professionals gathered in one place discussing automation issues. A range of companies participated including AbbVie, Amgen, Biogen Idec, BMS, Genentech, Genzyme, GSK, Eli Lilly, NNE Pharmaplan, Novo Nordisk, and Pfizer.
Topic: Track and Trace Serialization (TnT)
As government agencies and the pharmaceutical & life sciences industry take measures to reduce drug counterfeiting, product diversion, and increase patient safety, drug manufacturers are faced with the challenge of implementing serialization and tracking systems. Countries around the world are planning to require track and trace requirements. California’s e-Pedigree requirements for prescription drugs will take effect on a staggered basis starting in January of 2015. The term “e-Pedigree" means a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the drug. The presenter noted Track and Trace Serialization is not yet harmonized throughout the world.
There are a number of motivations for close tracking including dealing with contamination recalls, counterfeit drugs and drug thefts. The street value of drugs can easily range from $15-$50 per tablet or in the case of codeine, which has a value of $200-$300 per pint. There have been thefts of pharmaceuticals in transit that have ranged from $2 million to $80 million per incident. The presenter also commented that Viagra is the most counterfeited drug.
Many countries are in the process of establishing or formalizing standards for healthcare to improve patient safety, improve supply chain efficiency, and reduce reimbursement fraud. It is the long term interest of pharmaceutical companies to support these efforts. Since there needs to be tracking throughout the supply chain, standards are a fundamental part of making this work.
GS1 Standards, which are already used in 25 different global industry sectors, offer the best opportunity to achieve this single global standard. GS1 is an international not-for-profit association with members in over 100 countries. GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. These standards define how products, services and businesses are identified for electronic commerce purposes, by using alpha numeric characters formatted in a specific fashion. These specifically formatted identifiers are commonly represented on products as 2D data matrix barcodes or RFID tags used by automatic identification systems to avoid data transfer errors.
An equipment example is an on-line carton (item level) serialization work cell that incorporates an inkjet printer for printing unique data such as batch codes, expire dates and 2D barcodes. Vision inspection systems would be used to verify the printed data and trigger fast sorting using a high pressure air jet.
All the information collected in production on the packaging line needs to be stored in the enterprise business system. In the future interoperable world of distribution, this information can be sent to the pharmacies where product is delivered to the consumer. The operation of the configuration described in the presentation starts at the enterprise level that assigns serial number ranges to a Global Trade Item Number (GTIN). The GTINs are loaded into a plant site manager server that allocates serial numbers in blocks to production line systems and prints labels and/or applies RFID. There are country specific requirements that they are striving to cover with one approach. The challenge is there are already over 20 world standards with requirements evolving in each country and as requirements are added they will need to be accommodated. They are also putting a unique serial number on each unit component including item, case, shipping cases, and pallet. These are all part of a hierarchy with parent-child relationships. For example, given a pallet identifier, the user can determine what cases and bottles are in the pallet. This also requires handling exceptions such as product damage and batch changes. The system needs to decommission the product that relates to the serial numbers and identifiers.
PAR Group Discussion Comments
Individual PAR members from other biopharmaceutical companies injected the following comments on this topic:
“We have very large global program that is very expensive. We have the same issues with changing requirements worldwide. We have to constantly shift resources based on changing timelines. One difference is we are using laser ablation for printing rather than inkjet.”
“An issue is keeping a line running if communications is lost with the enterprise.”
“The serial numbers are valuable and require cyber security protections.”
“A big challenge is this implementation requires cross discipline between packaging, automation, and IT.”
“A big issue on existing production lines is finding room for the new equipment.”
“There is a big impact on efficiency. We are estimating 3-5% lower efficiency once the system is commissioned and running.”
“The challenge is with the technology vendors who are still developing and trying to bring on resources.”
“Throughout the company we have multiple ERP systems that will need to communicate to these systems.”
“Our program scope changed after our budgets are set. Due to changing requirements, what you installed is not quite meeting the new needs.”
“The general view of the group is that Track and Trace Serialization is going to add a great deal of cost and complexity to capture, track and archive data.”
Other Articles in this PAR Series:
- Part 1 - Management’s View of Automation - Impressions of Automation Performance
- Part 2 - Managements View of Automation - Investment Value
- Part 3 - Management's View of Automation – Focus of Improvements
- Part 4 - Integrated Manufacturing Systems
- Part 5 - Real Time Data Integration and Dashboarding
- Part 6 - System Obsolescence Planning
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