Serialization Survey May 2011 PharmTech Inc

8/3/2019 Serialization Survey May 2011 PharmTech Inc

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2011 PharmTech, Inc. All Rights Reserved

Serialization & Traceability:

Where are you?Pharmaceutical Industry Survey : Executive Summary

May 2011

By Michael Stewart

PharmTech, Inc.

Survey Sponsored by:

www.PharmTechInc.com
http://www.pharmtechinc.com/http://www.pharmtechinc.com/


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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 downto 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 theprocess 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 actionabledata 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.


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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


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Awareness

0

10

20

30

40

50

60

70

80

90

CA SB1307 France CIT13 FDA SNI

Guidance

Turkey I.T.S. Unaware of

any

Awareness of Guidelines

In general, most companies were aware of the California e-Pedigree and serialization bill andthe 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.

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 aserialization 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.

0

20

40

60

6m 1 Yr 2 Yr 3+ Yrs

How Long Do You Expect a Full Implementation of a

Traceability Solution to take ?


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Business Value

0

10

20

30

40

50

60

70

80

90

100

What business functions benefit from traceability and

real time supply chain visibility?

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.


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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 ComplianceOnly Issue.

0%10%20%30%

40%50%

60%

70%

80%

90%

100%

Not a Concern

Not Very Challenging

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 thatthere is inherent value built into their customized traceability system.


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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 ReadinessAnalysis (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 QualityManagement Systems, Technology Integration and Traceability Systems in consulting for FDAregulated 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 advantageto increase business value and Return on Investment (ROI).

Our staff averages in excess of 10 years of industry, compliance and consulting experience. Wework to give you ROI from the projects you are required to undertake, whether compliancerelated or not, and gain long-term value in an ever changing business climate. As a result, youare able to quantify your business objectives and realize significant return on your investmentsby leveraging technology and strategic data management.

Serialization Survey May 2011 PharmTech Inc

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