Pharmaceutical Serialization:

An Implementation Guide
By Joe Whyte, Global Serialization Lead, Rockwell Automation

Global pharmaceutical companies lose an estimated

$75 billion annually to counterfeit, gray market and stolen
product. Impending regulations aimed at protecting public
health, intellectual property and national security will require
pharmaceutical, medical device and consumer packaged-goods
manufacturers to track and trace products across the
supply chain.
This white paper gives in-depth descriptions of the:
• Challenges driving new serialization regulation.
• Pending regulation requirements and deadlines.
• Implementation and interoperability challenges in
pharmaceutical serialization solutions.
• New holistic pharmaceutical serialization solution from
Rockwell Automation® built on a modular and scalable
off-the-shelf control and information platform.
• Business benefits of the common data source created
by pharmaceutical serialization.
2 | Pharmaceutical Serialization: An Implementation Guide

Summary
No corner of the world is safe from counterfeit pharmaceuticals. In the United States,
contaminated blood thinner medication killed dozens of Americans and sickened many
more in 2008. In New Zealand, women who bought do-it-yourself Botox on the Internet
in 2011 were disfigured by impurities – including cooking oil – contained in the bogus
injections. In sub-Saharan Africa today, according to the Centers of Disease Control,
an estimated 30 percent of all drugs are counterfeit, and often contain little or none
of the active ingredients patients need to battle malaria, tuberculosis and other
life-threatening diseases.
While the human suffering caused by counterfeit drugs is incalculable, experts estimate
that global pharmaceutical companies lose an estimated $75 billion annually to rogue
dealers, including those involved in organized crime and even terrorist groups.1
That total doesn’t include less tangible but still substantial losses to pharmaceutical
manufacturers from diminished brand value caused by damaged public trust.
By all accounts, trafficking in illicit pharmaceuticals – including
sham, stolen or otherwise diverted prescription medications –
is far more lucrative than selling illegal drugs. The U.S. Department
Pharmaceutical companies of Commerce estimates that a $1,000 investment in counterfeit
lose an estimated $75 billion prescription drugs can result in a $30,000 return – ten times the
profit margin for heroin.
annually to rogue dealers … a
Alarmed by the proliferation of counterfeit medications – as well
total that does not include losses as fake medical devices and contaminated consumer products,
from damaged public trust and such as baby formula – countries around the world are taking
action. Impending regulations aimed at protecting public health,
diminished brand value. intellectual property rights and national security will require
pharmaceutical, medical device and consumer packaged-goods
manufacturers to track and trace products across the supply chain.
Until now, only production-related information, such as the expiration date and lot codes,
has been printed on products and their final packaging. However, serialization –
the application of a unique alpha or numeric identifier on every pharmaceutical package
down to the unit level of sale – is a common requirement among the otherwise disparate
international initiatives scheduled to take effect in the next several years.
These unique identifiers must be stored in a database along with other information
about the item, including manufacturer and batch details. Using unique serial numbers,
the authenticity of items can be verified against the database at every step in the
distribution chain, from the manufacturer to the consumer.
Brazil is leading the serialization charge. All packaging on prescriptions sold in the country
must carry a two-dimensional (2-D) code to enable monitoring from the factory to the
pharmacy – including identification of the individual who purchased a particular drug.
But that’s just Brazil. GS1, an international organization that develops and maintains
standards for supply and demand chains across multiple sectors, has created many
standards to support serialization – down to what a 2-D barcode looks like. GS1’s EPCIS
does provide details on managing and sharing data between parties who have EPCIS
certified systems. However, there is no global agreement on a central or distributed
database or data ownership model.

1
http://www.stimson.org/images/uploads/research-pdfs/Full_-_Counterfeit_Drugs_and_National_Security.pdf
 Pharmaceutical Serialization: An Implementation Guide | 3

To ensure compliance and patient safety, pharmaceutical manufacturers need a flexible

technology and new expertise to help them navigate the production and cultural
complexities of emerging serialization regulations. They need seamless interoperability
among all machines, devices, business systems and databases that together comprise the
pharmaceutical supply chain.
A new holistic serialization solution from Rockwell Automation, which can be globally
deployed and supported consistently, helps pharmaceutical manufacturers overcome
these challenges. That’s because it is built on a modular and scalable off-the-shelf
control and information platform that can be easily integrated into drug makers’ existing
production lines.
The solution integrates with GS1 Electronic Product Code Information Services (EPCIS)
certified central database to seamlessly and securely share data from the enterprise, to
supply-chain partners and the retail point of sale – and potentially, right to the customer.
The business benefits of this holistic solution extend well beyond stopping counterfeiters
and thieves. With a clear line of sight through the supply chain, drug makers can optimize
their manufacturing, supply chain processes, and their product inventories, to meet real
time consumption demands. Manufacturers can also improve the accuracy and reduce
the scope of product recalls. Finally, the common data source created by serialization
can yield valuable, actionable intelligence for departments, ranging from finance to sales
to marketing.

Human Harm
Nearly a decade ago, the World Health Organization (WHO) launched the International
Medical Products Anti-Counterfeiting Task Force (IMPACT) to “halt the production,
trading and selling of fake medicines around the globe.”2
IMPACT members included international enforcement agencies, pharmaceutical
manufacturers’ associations, and drug and regulatory authorities. Since 2006,
members have collaborated on international criminal investigations, helped countries
strengthen their detection and enforcement systems, and worked with industry to
develop prescription supply-chain protections, such as secure, high-tech
pharmaceuticals packaging.
Still, the number of people harmed by counterfeit, contaminated, stolen and otherwise
compromised medications has continued to grow, along with the sophistication of the
criminals who peddle them.
Using advanced and readily available technologies, it’s easy for counterfeiting criminals
to produce a pill or a vial that looks like the real thing and create copy-cat packaging that
appears authentic.
That was the case in 2012, when the U.S. Food and Drug Administration (FDA) reported
that a counterfeit version of cancer drug Avastin had invaded the U.S. supply chain.
The fake injectable serum – seized mostly from unsuspecting doctors, clinics and
hospitals – contained cornstarch, acetone and other chemicals, but no active ingredient
to fight cancer. 3

2
http://www.who.int/medicines/services/counterfeit/overview
3
http://www.wsj.com/articles/SB10001424052702303879604577410430607090226
4 | Pharmaceutical Serialization: An Implementation Guide

Overall, industrialized countries are less vulnerable to counterfeit prescription drugs than
less developed nations. An estimated 10 to 30 percent of medicines sold in developing
countries are fake, according to U.S. Centers for Disease Control (CDC), but less than
one percent of prescription drugs sold in America, the European Union, Japan, Canada,
Australian and New Zealand, are counterfeit. 4
In the developed world, most manufacturers are diligent about quality control and
adhering to good manufacturing practices (GMP). However, under-regulated wholesalers
and re-packagers are increasingly involved in the prescription supply chain. The explosion
in Internet pharmacies has given counterfeiters unprecedented access into the already
complex and fragmented prescription supply chain.
Case in point is a 2013 analysis by the National Association of Boards of Pharmacy, which
accredits online pharmacies. It showed that 97 percent of the more than 10,000 online sites
selling prescription medications were operating illegally or not following pharmacy laws
and standards. According to the WHO, more than 50 percent of prescription medicines
purchased over the Internet from illegal sites have been found to be counterfeit.

Rogue Agents
Drugs in almost every therapeutic category have been counterfeited, but certain types of
fake medicines are more prevalent in different parts of the world.
In developed nations, counterfeiters tend to focus on expensive lifestyle medications,
such as erectile dysfunction and anti-allergy drugs. In one of many such cases, three British
men were sentenced to prison in April 2015 for selling fake Viagra. 5 The judge in the case
said the men were part of a “highly organized, large-scale criminal enterprise” that used a
bogus mail-order fishing-tackle business to reap an average of £60,000 a week.
In the developing world, counterfeiters tend to target drugs used to fight infectious
diseases. For instance, a 2012 study published in the journal Lancet showed that up to
36 percent of anti-malarial drugs collected in Southeast Asia were falsified, while in
sub-Saharan Africa, a third failed chemical analysis. 6
Counterfeiters aren’t the only rogues in the
The lack of trace-and-track pharmaceutical business.
transparency in the prescription Gray market companies operating outside the legitimate drug-
supply chain leaves open distribution chain buy and sell prescription drugs. “When critical
medications become scarce and are no longer available through
questions about the quality and a hospital’s usual channels of distribution, unscrupulous gray
efficacy of gray market medicines. market distributors have been quick to jump in with inexplicably
As the FDA notes, “It is unknown obtained supplies of these drugs that they are more than willing
to sell to health care providers at exorbitant costs,” according to
how these drugs are stored and the Institute for Safe Medication Practices. 7
handled, or whether they are The lack of trace-and-track transparency in the prescription
expired, counterfeit or supply chain leaves open questions about the quality and
otherwise substandard.” efficacy of gray market medicines. As the FDA notes,
“It is unknown how these drugs are stored and handled, or
whether they are expired, counterfeit or otherwise substandard.” 8

4
http://www.cdc.gov/features/counterfeitdrugs
5
http://www.theguardian.com/uk-news/2015/apr/13/fake-viagra-gang-members-sentenced-criminal-enterprise
6
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70064-6/fulltext
7
https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=3
8
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm277747.htm
 Pharmaceutical Serialization: An Implementation Guide | 5

Meanwhile, illicit prescription-drug dealers – ranging from organized gangs, to corrupt

doctors, to teens raiding their parents’ medicine cabinets – are fueling an epidemic in
prescription opioid addiction. Abuse of narcotic painkillers, such as OxyContin, Percocet
and Vicodin, kills 45 people per day in the U.S., according to the CDC. That’s more than
deaths from heroin and cocaine overdoses combined. 9

Regulatory Sea Change

These stark human realities, combined with lost profits and a lack of security in the world’s
drug supply chain, have led to an international transformation in prescription medicine
regulations.
In 2015, South Korea joined Turkey and Argentina in requiring prescription drug items sold
in their countries to be serialized. They must now include both human- and machine-
readable symbols, such as a GS1® DataMatrix and a unique serial number for each item.
GS1 standards are the most widely used in supply chains across the world. Its identification
system includes globally unique identification for products, assets (objects) and locations,
as well as its standards for capturing and sharing visibility and traceability data between
supply-chain partners and other key stakeholders. Virtually every country besides China
has adopted GS1 standards for pharmaceutical serialization “to minimize fragmentation
and instead increase harmonization worldwide.” 10
In Brazil, government officials are developing a requirement in
which drug makers must provide serialization and tracking data
Industry organizations, such for three batches of products.

as the European Federation of In the United States, new requirements for serialization and
traceability under the Drug Supply Chain Security Act of 2013
Pharmaceutical Industries and will be phased in over a decade. At the beginning of 2015, the
Associations, are drafting and government began requiring that manufacturers incorporate
product-transaction data into a single document that is available,
piloting technological solutions to either electronically or on paper, each time ownership is
transferred. By November 2017, that information must be available
meet the serialization mandates. electronically, and the product identifier must be affixed or
imprinted on the label at the product and case level.
By 2023, U.S. mandates will require manufacturers to be able to
exchange transaction information and transaction statements in
an interoperable electronic manner. A full transaction e-pedigree will be defined by the
FDA prior to the required implementation in November 2023.
In the European Union, with the publication of the Delegated Act on safety features in
February 2016, manufacturers have to comply until 2019 with new Serialization regulations
outlined in the Falsified Medicines Directive (FMD).
These changes comprise just the first wave of new track-and-trace legislation.
Pharmaceutical serialization requirements are in various stages of development in more
than a dozen counties from China to Mexico to Saudi Arabia.

9
http://www.cdc.gov/drugoverdose/data/index.html
http://www.gs1.org/docs/healthcare/Joint_Industry_Position_Paper_on_Serialization_and_Product_
10 

Verification_Final_November_2013.pdf
11
http://www.healthcarepackaging.com/playbooks/pharmaceutical-serialization-playbook
6 | Pharmaceutical Serialization: An Implementation Guide

Interoperability Challenges
For pharmaceutical companies, these deadlines have created a huge quandary. The
major challenge: While the regulations spell out serialization as the solution to protect the
pharmaceutical supply chain, they don’t specify how to implement a serialization solution.

Pharmaceutical Serialization: Defining Terms

Product Serialization is the application of a unique alpha or numeric identifier on every

pharmaceutical package, from the unit level of sale to the pallet. Serialization will be required under
impending international mandates aimed at protecting the prescription-drug supply chain from
counterfeiters, thieves and other threats.

Aggregation is the relationship between the primary package and every subsequent container or
package used to ship the saleable unit of a prescription drug. In serialization, aggregation is both a
physical relationship and a data relationship. For example, each carton, case and pallet that contains
the unit of sale requires a unique serial number. Those associated serial numbers are collected
in a database, and used to track prescriptions throughout the supply chain, from the point of
manufacture to the consumer.

E-pedigree is a chain-of-custody document that identifies each prior sale, purchase or trade of a
drug, including the date of those transactions, and the names and addresses of all parties involved.

Electronic data interchange (EDI) is the transfer of data from one computer system to another by
standardized message formatting, without the need for human intervention. EDI permits multiple
companies – possibly in different countries – to exchange documents electronically. It is the most
common method used by drug makers today to share serialization information and serialized
content-to-container relationships with trading partners.

Electronic Product Code Information Services (EPCIS) is a GS1 standard that enables supply-
chain partners to store and share physical event data, including the what, when, where and
why about physical observations (events), independent of the technology used to capture that
information. This allows companies to associate and share additional information, or events, relating
to an object’s identity. For example, companies can associate information, such as the time and date
that a bar code was scanned or an RFID tag was read, the location of that scan/read, and whether
the object was being shipped or received. 12

There also is not an agreed-upon data format for capturing aggregated track-and-trace
information and sharing it among multiple trading partners in the global supply chain.
Within the four walls of the factory, implementing the new regulations requires tracking
at every stage in the end-of-line packaging process down to machines, printers, labelers,
bar-code scanners and vision systems.
 Pharmaceutical Serialization: An Implementation Guide | 7

At each stage in the finished goods packaging process, a unique serial number –
represented by a 2-D barcode or RFID tag – must be applied to the product’s package.
Depending on the industry or customer need, there can be up to five levels of parent/child
aggregation, with serial numbers applied to the item level or unit dose, up to the pallet.
The unique serial number at each stage in the packaging process must be married to all
the unique serial numbers contained in the package. Therefore, each pallet serial number
(parent) is paired to all the unique case serial numbers (children) on the pallet, creating
the aggregated parent/child relationship. Likewise, each case
serial number (parent) is paired to all of the unique carton serial
The unique serial number at each numbers (children) that are in the case, and so on.

stage in the packaging process Accurately applying and associating these new and complicated
sets of individual identifiers poses interoperational challenges for
must be married to all the unique many drug makers. That’s because historically, pharmaceutical
serial numbers contained in companies have invested in “black box” solutions at the
the package. packaging-line level. Those can include unique hardware – such
as their own versions of printing and vision systems – as well
as custom software drivers, custom application software and
proprietary networks.
For data generation and acquisition, serialization is complicated by the massive need for
unique applied numbers (preferably randomized), the high volume and speed of the
data-handling process, and the wide range of products, formats and country requirements.
Serialization also adds extra layers of information that must be integrated into existing
production processes and information systems. Information must flow between control
systems, manufacturing execution systems (MES), enterprise resource planning (ERP)
systems, inventory management and supply-chain systems.
Beyond the pharmaceutical plant, products can change ownership as many as 10 times
within the supply chain before reaching patients. 12 These transition points in the supply
chain are essentially the vectors of attack for anyone sophisticated enough to steal or
otherwise divert prescription drugs from the legitimate supply chain. 13
Effectively meeting the new government mandates will require a holistic serialization
solution to track and trace prescription drugs through the entire supply chain.
Today, electronic data interchange (EDI) is the most common method used by drug
makers to share serialization information and serialized content-to-container relationships
with trading partners. However, EDI file-sharing wasn’t designed for tracing supply-chain
event data. It has no query mechanism, no exceptions processes, no global format, and
most important of all, it is not extensible without Standards action, which would require a
multi-year process. Extensibility is a software design principle defined as a system’s ability
to have new functionality extended, in which the system’s internal structure and data
flow are not affected, an essential element if a platform is to adapt to new and emerging
regulatory requirements. EDI doesn’t amount to much more than a text file combined with
an advance shipping notice, much like how consumers track their FedEx packages today.
GS1 has developed EPCIS to overcome shortcomings with EDI and accommodate the
growing volume and complexity of data required by emerging serialization legislation.
EPCIS enables supply-chain partners to store and share physical event data, including the
what, when, where and why of events, independent of the technology used to capture
that information. 14

12
http://www.pharmacompliancemonitor.com/global-pharmaceutical-product-serialization-taking-steps-against-
counterfeiting/8831/
13
http://www.healthcarepackaging.com/playbooks/pharmaceutical-serialization-playbook
8 | Pharmaceutical Serialization: An Implementation Guide

This allows companies to associate and share additional information, or events, relating to
an object’s identity. For example, companies can associate information, such as the time
and date that a barcode was scanned or an RFID tag was read, the location of that scan/
read, and whether the object was being shipped or received.
Ultimately, as a product is scanned through the supply chain, if a serialization identifier
shows up somewhere else in the system, it’s a red flag that there’s a counterfeit in the
market. This enables manufacturers to take action before it gets into the hands of
the consumer.

A Holistic Serialization Solution

A new holistic serialization solution from Rockwell Automation enables pharmaceutical
manufacturers to comply with the current regulations and standards with the flexibility to
adapt to those on the horizon.
The solution is built on industry standards (IEC 61131, ANSI/ISA-88, ANSI/ISA-95) and uses
open network and communication protocols, and commercial off-the-shelf technologies,
eliminating the need for black-box proprietary control solutions and the associated custom
interfaces and custom drivers that they require. This open approach allows Rockwell
Automation to deliver a modular, re-usable and scalable solution anywhere in the world,
using local resources
This turnkey solution aligns to the ISA-95 multilayer data model. More specifically,
it contains key modifications/additions to the packaging-line data structure to:
• Completely separate machine control and data functionalities.
• Create a single database that manages information throughout the serialization process.
• Provide the required data links and Web services to connect serialization data to the ERP
layer and the Supply Chain Cloud.

ISA-95 Serialization Levels

Level 0: Production process data Printers, Labelers, Vision Systems & Bar Code Scanners:
(e.g., I/O, devices) Serialization numbers printed and inspected
Level 1: Sensing/testing equipment or Unit Level Controller and HMI Stations: Serialization and
instrumentation (e.g., HMI, sensors) aggregation data management per station
Level 2: Control the production processes Line controller serialization and aggregation data
(e.g., SCADA, HMI, batch) management for the entire packaging line
Level 3: Work flow/recipe management, Site Server: Serialization and aggregation data management
electronic records, production management for the entire facility
(e.g., MES)
Level 4: Business planning and Business planning and logistics: Serialization interface
logistics (e.g., ERP) to ERP and MES
Level 5: Supply Chain Track and Trace Serialization Data
Event Repository
Serialization-relevant data is widely distributed over control and information systems across many levels or layers.
Rockwell Automation identifies these layers based on the enterprise and control system levels of the ISA-95 data model.

The system integrates with EPCIS certified supply chain repositories to specifically meet
serialization regulatory requirements.

14
http://www.gs1.org/docs/GS1_Anti-Counterfeiting_White_Paper.pdf
 Pharmaceutical Serialization: An Implementation Guide | 9

Here’s how the holistic Rockwell Automation solution works at each level of its ISA-95
aligned data model:
Level 0, according to the traditional ISA-95 standard, is the device level that includes
pieces in the packaging machine, such as vision systems, printers and radio-frequency
identification (RFID) systems.
The Rockwell Automation solution expands Level 0 to include
the packaging machine itself, which was separate at Level 1 in
the traditional ISA-95 model. This modification keeps all the
Free of proprietary equipment equipment responsible for packaging the product on the same
level. To ensure all the machines and their components operate
and networks, pharmaceutical seamlessly – and allow the solution to be scalable and
producers can choose from repeatable – all the physical assets are commercial off-the-shelf
(COTS) technology.
a wider selection of OEMs for
Separating the machine functions from the data functions not
troubleshooting or repairs. only creates a consistent information solution – it also empowers
OEMs to deliver serialization-ready machines without the
complexities entailed in adding IT data capabilities. With the
Rockwell Automation solution, the machine-controller level
isn’t responsible for managing data or generating serialization identifiers as they do on
many existing packaging lines. The Rockwell Automation solution keeps those critical and
increasingly sophisticated data functions above Level 0.
A side benefit for packaging-machine end users: Free of proprietary equipment and
networks, they can choose from a wider selection of OEMs, Systems Integrators and
Solution Providers to provide and integrate Level 0 devices and packaging machinery
or to provide deployed system repairs or troubleshooting support services.
10 | Pharmaceutical Serialization: An Implementation Guide

Level 1 in the Rockwell Automation architecture is home to a serialization Allen-Bradley®

CompactLogix® processor – a COT – that manages the serial information interface
between the data layers and the Level 0 devices and packaging machinery and acts as
a serialization data buffer between the data and equipment layers. Level 1 dedicated
programmable automation controllers (PACs) manage the serialized data at each stage in
the Level 0 packaging process (from primary to palletizer packaging), and send the printed
and verified numbers to the Level 2 line controller where the required parent-child data
relationships are created and managed.
Level 2 is the line controller responsible for managing the data associated with each
packaging line’s dedicated PACs. Rockwell Automation uses an Allen-Bradley ControlLogix
processor – a COT – that operates as a data concentrator and acts as a serialization data
buffer. It manages the serialized numbers specific to each packaging aggregation unit on
the line during a production run and creates the required parent/child data relationships.
The level 2 line controller receives those unique, random identifiers from the site server
at Level 3, and then distributes them among the different controllers on Level 1. Not all
those numbers will be used during the production run because of bad prints or rejected
products. The Level 2 line controller maintains a “good” list until the run is completed.
This ensures only good products are included in the next packaging aggregation unit.
These results are buffered and continuously uploaded to the Level 3 site controller which
operates as a central database.
Level 3 is the site server, which manages all of the serialization data for a manufacturing
plant and ensures that the right serial number is at the right place, at the right time
throughout the facility. The site server is the only plant level database in the Rockwell
Automation solution, which helps ensure data integrity for the entire system.
The site server identifies, quantifies and classifies the serial numbers to be sent to the
packaging line, based on a production order. It marries that production order to the
serialization information that needs to be applied to all the products and all the packaging
levels in one location. It then provisions that data to the appropriate machines on the plant
floor via the line controller on Level 2.
Level 3 uses a dedicated serialization module built on top of the FactoryTalk® PharmaSuite™
software application. It uses the ERP Integration Gateway to provide the required
connectors to MES, ERP or cloud-based track-and-trace systems. .
Level 4 is the corporate IT business layer where ERP systems track business resources
and convert customer orders into production runs. Once serialization data enters the
Level 5 supply chain, drug makers can use the product tracking data to improve business
operations throughout their enterprise. They can optimize everything from inventory
levels to product promotions to rebates and chargebacks. All this is possible by taking
serialization data from a nonproprietary platform and seamlessly integrating it into
business information systems.
Level 5 is the cloud-based, supply-chain event repository where a company’s serial
numbers for each production site should originate and to which all authenticated
aggregated serial data should be sent for storage. The Level 3 Site Server can directly
interface to any Level 5 system, thus providing customers with a robust and secure
central database with worldwide availability. Once products leave a manufacturing site,
all supply-chain events associated with each package are tracked and stored in the event
repository as the products move to the final point of sale.
 Pharmaceutical Serialization: An Implementation Guide | 11

The Rockwell Automation serialization solution includes an interface to a Cloud-based

repository, which gives manufacturers the flexibility to implement the appropriate
Level 5 solution that allows them to provide the required information to regulatory
bodies. Certain countries will have exceptions. China, for instance, is expected to create
a central government repository.
By using the Cloud to maintain their databases, manufacturers have the ability and the
server capacity to manage their product’s chain of custody from anywhere in the world
via a Web portal.

Cloud-Based Data Event Repository

Deploying a successful supply chain cloud solution requires a disciplined process.
That’s why the Rockwell Automation serialization solution provides an out-of-box
connector to cloud-based serialization and track-and-trace platforms. The Level 5
cloud-based, supply-chain, event repository server is EPCIS-certified, meaning it meets
GS1 guidelines for providing global drug pedigrees and for interoperability with IT
service standards.
The Level 5 platform can offer cloud-based event repository, packaging-line serialization
configurations, and front-end applications to derive business benefits from serial numbers.
The platform is designed to accommodate the additional data required to conform
to EPCIS standards, as well as the current data exchange associated with EDI. The
challenge of generating and managing the millions of random numbers required for
serialization is complex. The Level 5 platform integrates with the Rockwell Automation
solution, delivering serialization numbers to the central site server at Level 3. This helps
automatically track those unique numbers – including those provisioned but not used on
the packaging line – to ensure the integrity of the system and prevent any redundancy.
To conform with emerging chain-of-custody regulations, the path of prescription drugs
through the supply chain must be tracked and recorded at every step – by distributors,
hospitals, pharmacies, etc. the EPCIS cloud-based event repository automatically uploads
scanned serialization information and updates the customer’s database.
The platform has applications that allow drug makers to perform analytics on their supply
chain data to identify counterfeit or diversion activities. Pharmaceutical companies also can
explore the data-mining capabilities of cloud platforms to potentially streamline processes
and identify business opportunities.
Microsoft, a Rockwell Automation Strategic Alliance partner, has developed its Azure
platform as a globally distributed and redundant cloud environment with more than 150
data centers worldwide. These geographically dispersed data centers comply with key
industry standards, such as ISO/IEC 27001:2005, for defense-in-depth security and reliability.
Microsoft’s data centers are managed, monitored and administered with 24/7
continuity by operations staff who have years of experience in delivering the world’s
largest online services.
12 | Pharmaceutical Serialization: An Implementation Guide

Delivery and Support of Mission Critical Assets

Once the regulatory deadlines are past, if any part of the serialization system in a plant
stops working, the entire production line can no longer produce product. That’s a mission-
critical production asset down.
Rockwell Automation can help get that key asset up and running quickly by leveraging its
core capabilities of secure remote access and serialization application diagnostics.
Because the Rockwell Automation serialization solution is based on a standardized model,
its data solution allows Rockwell Automation support, locally based OEMs or system
integrators to remotely access pharmaceutical facilities through a firewall controlled by the
in-house IT department.
Users with black-box control or custom control systems often encounter long-term
support challenges, as well as parts and knowledge transfer issues.
With the regulatory deadlines rapidly approaching in many countries, many
pharmaceutical companies will need to deploy serialization solutions in multiple locations
simultaneously. Only a solution that uses commercial off-the-shelf technology that is easily
deployable and supportable can meet this challenge.
Rockwell Automation control systems are built on an open architecture that provides
the modularity, scalability and flexibility needed to comply with impending serializations
regulations. The Rockwell Automation solution also allows companies to reap the business
benefits that extend from a fully integrated serialization system.

Reverse-Logistics Benefits
A holistic and interoperable serialization solution can deliver reverse-logistics benefits from
more accurate and efficient recalls to improved forecasting and more customer-specific
marketing programs.
For example, imagine a pharmaceutical company discovers a supply-chain partner did not
store a specific ingredient for a drug at specified temperature or humidity levels. Today, the
producer would need to review data to understand which batches were impacted. They
would likely add the previous and trailing batches to the recall to be safe, determine which
pallets those were shipped out on, and guesstimate what happened to those pallets after
they were received by a third party. They would need to rigorously publicize the recall and
impacted batch numbers to ensure product was not consumed as they couldn’t directly
contact the point-of-sale outlets.
With a holistic serialization solution, the producer could use the data thread to track
backward along their distribution chain. They could quickly and easily utilize their cloud-
based data repository to determine which cases or packages were on pallets that shipped,
as well as where they were shipped from there onto the final point of sale. Those retail
outlets could be contacted directly to remove the damaged product and only the
damaged product from the shelves. If the point of sale had information on the consumers
who purchased the damaged product, they could potentially reach out to the consumer
directly to prevent any complications from the defective medicine.
But the solution offers more than this. Pharmaceutical innovators are following initiatives
like the Smart Manufacturing Leadership Coalition, Industrie 4.0 and China’s Manufacturing
Intelligence 2025. Admittedly, though, many don’t yet have a clear strategy in place to
operationalize these initiatives.
 Pharmaceutical Serialization: An Implementation Guide | 13

Success today requires greater process knowledge – the kind locked deep inside
production systems. Accessing that data and converting it into useful information can yield
tremendous benefits, but information alone isn’t enough.
Cross-departmental activity between plant-floor and front-office systems has become
particularly necessary in the life sciences industry, as tracking and reporting has evolved
from a nice-to-have to a must-have. Rockwell Automation refers to this as The Connected
Enterprise. It’s the creation of a unified control and information system architecture to
harness production intelligence and improve operations across the product life cycle –
from formulation to factory.
Because the new Rockwell Automation holistic serialization solution is fully integrated
across the supply chain, all enterprise and control system levels, and potentially directly
to the customer, its common serialization data thread provides real-time visibility to
a company’s products and customers. What pharmaceutical producers can do when
empowered with this information is only limited by their imagination.
 
Resources
Rockwell Automation
Joe Whyte
Global Serialization Lead
700 Lanidex Plaza
Suite 7102
Parsippany, NJ 07054
Mobile: 973.768.3617
E-mail: jwhyte@ra.rockwell.com
http://www.rockwellautomation.com/sites/rockwellsoftware/applications/product_serialization.page

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Publication LIFESC-WP001C-EN-P – October 2017 Copyright © 2017 Rockwell Automation, Inc. All Rights Reserved. Printed in U.S.A.
Supersedes Publication LIFESC-WP001B-EN-P – April 2017