Executive Summary of the Serialization & Traceability survey conducted by PharmTech Inc. with pharmaceutical manufacturers executives and pharma supply chain partners on their stages and awareness on serialization and track and trace solutions.

1. Serialization & Traceability:
Where are you?
Pharmaceutical Industry Survey : Executive Summary
May 2011
By Michael Stewart
PharmTech, Inc.
Survey Sponsored by:
www.PharmTechInc.com
© 2011 PharmTech, Inc. All Rights Reserved

2. Introduction
In today s pharmaceutical regulatory environment, executives and management within the
industry are facing tough decisions when it comes to their supply chain and increasing
regulations. Several states in the U.S. have released guidelines requiring various forms of
pedigree (paper or electronic) while others have pushed for mass serialization all the way down
to the saleable item level.
Several years have gone by with the terms serialization, traceability and Track and Trace being
bantered about and concerns over when their implementation would be mandated. The
regulatory bodies have once again set their site on this topic and appear to be moving forward
with the discussion and clarifying to some degree the direction they want to proceed.
In February 2011, the FDA held a public workshop Developing a System for Track and Trace
and Authentication for Prescription Drugs to gather industry feedback on what their forthcoming
guidelines regarding traceability, pedigree and serialization should look like. The 2010 Joint
Strategic Plan on Intellectual Property , a report to the President of the United States,
recommended mandated use of electronic track and trace for pharmaceuticals and medical
products. In addition, the report states the need to implement a track-and-trace system,
which allows for authentication of the product and creation of an electronic pedigree
Internationally, serialization, pedigree, authentication and traceability in various forms is
underway namely through the efforts of Turkey, Brazil and France. India, China and Belgium as
well are moving forward on theirs. The topic is back on the front burner and regulatory action is
a given.
As industry insiders, we cannot deny that there is a renewed governmental interest and more
pronounced push towards establishing U.S. and international guidelines as to the acceptable
standards, how the events are reported and who has access to this data at each stage of the
process from manufacturer to final dispenser.
Although the driver by the FDA, states and international health ministries is patient safety, for
many pharmaceutical manufacturers in a world of shrinking margins, expiring patents, concerns
over counterfeiting, theft, diversion, recalls and the need for cost containment, this push by
regulatory bodies is being viewed as an opportunity to build in business value to what was
initially deemed a compliance project.
Traceability and serialization projects are now a way to manage supply chain data that until
recently would have been unavailable. Companies can build business engine rules around the
capture, use and dissemination of said information to management that can provide actionable
data to improve processes and provide real-time continuous improvement.
PharmTech, Inc. conducted a recent survey of pharmaceutical professionals to gauge four
specific areas surrounding serialization and traceability; Awareness, Readiness, Business Value
and Challenges to Implementation. The results offer an insight into the changing mindset
regarding serialization and traceability as a compliance burden towards how to use and
leverage this new information to improve the business and create a competitive advantage.
© 2011 PharmTech, Inc. All Rights Reserved

3. Participants
The companies in the survey were represented by pharmaceutical manufacturers (64%),
Contract Manufacturers (18%), Distribution/Wholesale partners (8%) and Other functions (10%).
Of the respondents, 72% were from North America, 18% from Europe and 10% from Asia.
Company Location
N. America
Europe
Asia
© 2011 PharmTech, Inc. All Rights Reserved

4. Awareness
Awareness of Guidelines
90
80
70
60
50
40
30
20
10
0
CA SB1307 France CIT13 FDA SNI Turkey I.T.S. Unaware of
Guidance any
In general, most companies were aware of the California e-Pedigree and serialization bill and
the guidance by the FDA on standardized numerical identifiers. Acknowledgement of
international legislation was mixed. While less than 10% of respondents were unaware of any of
the guidelines.
How Long Do You Expect a Full Implementation of a
Traceability Solution to take ?
60
40
20
0
6m 1 Yr 2 Yr 3+ Yrs
When we asked participants the implementation time from Let s do this to Flip the switch we
were surprised at the responses and underestimation of how large of a task implementing a
serialization and traceability solution is. Although nearly 60% of respondents expected the
timeline to be one year or less, the actual timeline for many large manufacturers can average 3-
5 years depending on the number of lines and products involved. The view that there is a plug
and play software/hardware solution that can be plugged in was prominent and increasingly
optimistic. Concerns over interoperability of IT systems, inventory build-up due to a line being
shut down for modifications, design of business rules engines, trading partner integration, data
access, data repositories and handling of queries etc were not even considered.
© 2011 PharmTech, Inc. All Rights Reserved

5. Readiness
To gauge readiness and proactive efforts, we asked a series of questions relating to what they
have done from a planning perspective followed by where they are in the implementation or
piloting stages.
Are you currently in a serialization pilot?
Have you conducted a serialization or traceability
readiness assessment?
Unsure
Unsure
No
No
Yes Yes
0 10 20 30 40 50 60 0 10 20 30 40 50 60 70
Approximately half of all participants had conducted some form of readiness assessment to
some degree, however over sixty percent have not begun to pilot.
Are you currently serializing at least one product?
No
Yes
0 10 20 30 40 50 60 70 80
© 2011 PharmTech, Inc. All Rights Reserved

6. Business Value
What business functions benefit from traceability and
real time supply chain visibility?
100
90
80
70
60
50
40
30
20
10
0
Each contributor had their own perception of what business value(s) having increased supply
chain visibility would create for each operational function. Recall management and Brand
Protection were the top two value drivers, however improving forecasting & planning,
distribution processes and inventory control ranked high as well. The assumption that
traceability serves a compliance only function is disproved as real tangible and quantifiable
business opportunities present themselves across all organizational and supply chain functions.
© 2011 PharmTech, Inc. All Rights Reserved

7. Challenges & Implementation
When asked about what the biggest organizational challenges are (were) with implementing a
traceability and serialization solution the responses were mixed. The three areas that were
considered the largest obstacle, ranking extremely challenging and somewhat challenging, were
Regulatory Uncertainty, Equipment Capital Expenditure and that traceability was a Compliance
Only Issue.
100%
90%
80%
70%
60%
50%
40%
30%
20% Not a Concern
10% Not Very Challenging
0%
Challenging
Somewhat Challenging
Extremely Challenging
The regulatory uncertainty and compliance only issue concerns will take care of themselves as
we have more firm regulatory guidance. The key component of the cost concern is what is
driving the need for business value built into traceability solutions. Even as a compliance or
regulatory concern, the cost of the equipment and processes does not change. Therefore,
management and operations are in need of identifying how to make these solutions not only
compliant, but work for them and create relevant and actionable data reporting to ensure that
there is inherent value built into their customized traceability system.
© 2011 PharmTech, Inc. All Rights Reserved

8. Challenges & Implementation
Thirty-five percent of the participants indicated they have implemented a traceability system or
are running a pilot. A full twenty five percent noted that they have no plans at this time to for a
traceability system to be implemented. That leaves forty percent of respondents looking to
develop, pilot and implement a traceability solution within the next year. Having seventy five
percent of those participating engaged at some level of traceability planning emphasizes the
understanding of forthcoming mandated traceability as well as the realization of additional
business benefits to moving forward.
When does your company plan to implement
a traceability or serialization system?
30
20
10
Currently Running Within 6 6 months 1 Year + No Plans
have one a Pilot months to 1 year
© 2011 PharmTech, Inc. All Rights Reserved

9. Parting Thoughts
In our daily engagements with pharmaceutical manufacturers at various levels of traceability
readiness, just starting to evaluate processes to those that are already serializing at least one
product, it is abundantly clear that the process from start to finish incorporates so much more
than just choosing a solutions provider. PharmTech recommends a Traceability Readiness
Analysis (TRA) for all manufacturers that are beginning to assess their organizations
preparedness and to indentify in advance exactly what systems, people, processes,
modifications, budget and timeline may be necessary as this all comes to pass. The Traceability
Readiness Analysis allows manufacturers to understand the framework of what needs to be
done and prioritize projects that can be tackled now, regardless of future regulations, and what
projects will be rolled out as necessary as the regulatory landscape is more defined. A typical
analysis through full implementation can take 3-5 years. For pharmaceutical manufacturers, it s
the question of How do you eat an elephant? Rather than being overwhelmed or frozen by the
enormous task in front of them, a Traceability Readiness Analysis will provide the road map to a
customized traceability solution that provides the much needed business value and return on
investment they expect and require while adhering to changing regulatory guidelines.
About PharmTech, Inc.
Founded in 1995 as a validation provider, our services have expanded to include Quality
Management Systems, Technology Integration and Traceability Systems in consulting for FDA
regulated industries.
As a leader in pharmaceutical consulting, PharmTech prides itself on not only showing you
where the industry is going, but providing you a road map to use those trends to your advantage
to increase business value and Return on Investment (ROI).
Our staff averages in excess of 10 years of industry, compliance and consulting experience. We
work to give you ROI from the projects you are required to undertake, whether compliance
related or not, and gain long-term value in an ever changing business climate. As a result, you
are able to quantify your business objectives and realize significant return on your investments
by leveraging technology and strategic data management.
© 2011 PharmTech, Inc. All Rights Reserved