Serialized ePedigree: From Planning to Execution - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Serialized ePedigree: From Planning to Execution
California's ePedigree requirements call for item-level serialization beginning in 2011. The author explains factors to consider when implementing a serialization strategy and how to achieve a positive return on investment.

Pharmaceutical Technology

Developing the implementation plan

Pharmaceutical manufacturers, distributors, wholesalers, and retailers must begin the process of implementing solutions that support ePedigrees, incorporate serialization down to the item level, and generate ePedigrees at each point of shipment. For organizations that have already begun the implementation process or have yet to start, the key is to understand where and how serialization impacts processes once the product leaves the manufacturing line and enters the supply chain.

Although the to-do list may seem overwhelming, it doesn't have to be. A solid serialized distribution plan is the first important step. When implementing a serialization strategy, many companies primarily focus on the finished product on the manufacturing packaging line, and, why not? The California requirement basically stipulates this. Many, however, do not realize that it is equally important to successfully manage the distribution of serialized product. By doing so, regulatory compliance can be realized more quickly.

There are three fundamental objectives and capabilities required for serialization within an organization's distribution operations as outlined below:
  • Serialization of drug product, typically at the item, case, and pallet level, and management of the associated parent-child relationships of these levels to the saleable unit
  • Tracking all product movement events such as receiving, putaway, picking, packing, and shipping of serialized product, for which data is integrated with the existing business processes and systems
  • Tracking the associated serialized product with a shipment to trigger the generation of the ePedigree.

Barcode versus RFID

The industry vision is that all pharmaceutical products will be serialized at the item, case, and pallet levels during the manufacturing process. To do so, manufacturers need to consider designing the capability to serialize product during the packaging process. The question arises, should pharmaceutical companies embrace radio frequency identification (RFID) technologies or use less costly barcodes? The answer to both questions is "yes."

EPCglobal, the governing body leading the development of industry-driven requirements for the Electronic Product Code, defined and ratified a number of serialization standards that offer direction for pharmaceutical companies implementing such solutions. Yet, industry still lacks a consensus on data-carrier technology. For simplicity, and to minimize costs, many manufacturers are leaning toward a 2D-barcode solution at the saleable item level and also at the case and pallet level. A barcode solution, however, makes the distribution process extremely difficult because each packed item requires a manual scan. Using barcodes does not generate the benefits of automatic identification RFID technology. Many distributors demand that manufacturers begin using the ultrahigh frequency RFID standard at the case level to minimize the complexity of the distribution process.

Getting started

If the lack of industry consensus on technology and data constructs has been an impediment to starting a company's implementation, there is reason to reconsider. There are several standards already ratified and more on the way covering the fundamental components of the serialization architecture such as tag data formats, data filter and collection, Electronic Product Code Information Services (EPCIS), and ePedigree. Many companies are effectively working with their trading partners to agree on interoperability standards in lieu of a final word from the industry. For example, in the consumer packaged goods (CPG) industry, brands such as Wal-Mart and Sam's Club adopted standards that suppliers must meet.

The key to a quick implementation is starting small while developing a business foundation for scaling up in the future. Early adopters' experiences have shown that companies are more successful in rolling out new pedigree and serialization technologies and business processes when they phase in implementation. It is important to work closely with partners to determine the best strategy and to ensure that processes are aligned. Be careful when jumping into a pilot serialization implementation project without considering how the entire enterprise will be affected by the change. As with most things, it's important to define a strategy and then execute. Consider the business implications of counterfeiting, diversion, and pedigree compliance, and how they relate to the organization.

Full pedigree and serialization compliance affects all products. Companies previously planning a risk-based approach to serializing products in a phased manner over time must think strategically about encompassing all products, including pipeline products. It will also be important to take other regulations into account and develop a single approach for nationwide full compliance and interoperability.

Understanding the technologies to use—and for what products—in a pragmatic and cost-effective manner is crucial to developing a cohesive product-security program. Until the industry ratifies standards, companies along the pharmaceutical supply chain will employ a wide range of data-collection technologies. Although a company may be starting with fewer stock-keeping units (SKUs), serialization solutions will need to use and support multiple technologies and data constructs. A serialization solution that uses both barcode and RFID technologies requires varying types of hardware. RFID technology requires tags and fixed-mount readers, and barcode technology uses fixed-mount or handheld scanners. Thus, the ideal serialization solution would allow for the capability to manage and orchestrate both types of data-carrier technologies.

Once a strategy is developed and understood, the company is better prepared to define the appropriate initial implementation, its timeline, and plan for the cost of the overall solution.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here