Serialization & Traceability Pharmaceutical Executive Survey by PharmTech


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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.

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Serialization & Traceability Pharmaceutical Executive Survey by PharmTech

  1. 1. Serialization & Traceability:Where are you?Pharmaceutical Industry Survey : Executive SummaryMay 2011By Michael Stewart PharmTech, Inc. Survey Sponsored by:© 2011 PharmTech, Inc. All Rights Reserved
  2. 2. IntroductionIn today s pharmaceutical regulatory environment, executives and management within theindustry are facing tough decisions when it comes to their supply chain and increasingregulations. Several states in the U.S. have released guidelines requiring various forms ofpedigree (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 beingbantered about and concerns over when their implementation would be mandated. Theregulatory bodies have once again set their site on this topic and appear to be moving forwardwith 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 Traceand Authentication for Prescription Drugs to gather industry feedback on what their forthcomingguidelines regarding traceability, pedigree and serialization should look like. The 2010 JointStrategic Plan on Intellectual Property , a report to the President of the United States,recommended mandated use of electronic track and trace for pharmaceuticals and medicalproducts. 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 pedigreeInternationally, serialization, pedigree, authentication and traceability in various forms isunderway namely through the efforts of Turkey, Brazil and France. India, China and Belgium aswell are moving forward on theirs. The topic is back on the front burner and regulatory action isa given.As industry insiders, we cannot deny that there is a renewed governmental interest and morepronounced push towards establishing U.S. and international guidelines as to the acceptablestandards, 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, formany pharmaceutical manufacturers in a world of shrinking margins, expiring patents, concernsover counterfeiting, theft, diversion, recalls and the need for cost containment, this push byregulatory bodies is being viewed as an opportunity to build in business value to what wasinitially deemed a compliance project.Traceability and serialization projects are now a way to manage supply chain data that untilrecently would have been unavailable. Companies can build business engine rules around thecapture, 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 fourspecific areas surrounding serialization and traceability; Awareness, Readiness, Business Valueand Challenges to Implementation. The results offer an insight into the changing mindsetregarding serialization and traceability as a compliance burden towards how to use andleverage this new information to improve the business and create a competitive advantage.© 2011 PharmTech, Inc. All Rights Reserved
  3. 3. ParticipantsThe 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. 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 anyIn general, most companies were aware of the California e-Pedigree and serialization bill andthe guidance by the FDA on standardized numerical identifiers. Acknowledgement ofinternational legislation was mixed. While less than 10% of respondents were unaware of any ofthe 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+ YrsWhen we asked participants the implementation time from Let s do this to Flip the switch wewere surprised at the responses and underestimation of how large of a task implementing aserialization and traceability solution is. Although nearly 60% of respondents expected thetimeline 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 plugand play software/hardware solution that can be plugged in was prominent and increasinglyoptimistic. Concerns over interoperability of IT systems, inventory build-up due to a line beingshut down for modifications, design of business rules engines, trading partner integration, dataaccess, data repositories and handling of queries etc were not even considered.© 2011 PharmTech, Inc. All Rights Reserved
  5. 5. ReadinessTo gauge readiness and proactive efforts, we asked a series of questions relating to what theyhave done from a planning perspective followed by where they are in the implementation orpiloting 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 70Approximately half of all participants had conducted some form of readiness assessment tosome 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. 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 0Each contributor had their own perception of what business value(s) having increased supplychain visibility would create for each operational function. Recall management and BrandProtection were the top two value drivers, however improving forecasting & planning,distribution processes and inventory control ranked high as well. The assumption thattraceability serves a compliance only function is disproved as real tangible and quantifiablebusiness opportunities present themselves across all organizational and supply chain functions.© 2011 PharmTech, Inc. All Rights Reserved
  7. 7. Challenges & ImplementationWhen asked about what the biggest organizational challenges are (were) with implementing atraceability and serialization solution the responses were mixed. The three areas that wereconsidered the largest obstacle, ranking extremely challenging and somewhat challenging, wereRegulatory Uncertainty, Equipment Capital Expenditure and that traceability was a ComplianceOnly Issue. 100% 90% 80% 70% 60% 50% 40% 30% 20% Not a Concern 10% Not Very Challenging 0% Challenging Somewhat Challenging Extremely ChallengingThe regulatory uncertainty and compliance only issue concerns will take care of themselves aswe have more firm regulatory guidance. The key component of the cost concern is what isdriving the need for business value built into traceability solutions. Even as a compliance orregulatory 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 onlycompliant, but work for them and create relevant and actionable data reporting to ensure thatthere is inherent value built into their customized traceability system.© 2011 PharmTech, Inc. All Rights Reserved
  8. 8. Challenges & ImplementationThirty-five percent of the participants indicated they have implemented a traceability system orare running a pilot. A full twenty five percent noted that they have no plans at this time to for atraceability system to be implemented. That leaves forty percent of respondents looking todevelop, pilot and implement a traceability solution within the next year. Having seventy fivepercent of those participating engaged at some level of traceability planning emphasizes theunderstanding of forthcoming mandated traceability as well as the realization of additionalbusiness 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. 9. Parting ThoughtsIn our daily engagements with pharmaceutical manufacturers at various levels of traceabilityreadiness, just starting to evaluate processes to those that are already serializing at least oneproduct, it is abundantly clear that the process from start to finish incorporates so much morethan just choosing a solutions provider. PharmTech recommends a Traceability ReadinessAnalysis (TRA) for all manufacturers that are beginning to assess their organizationspreparedness and to indentify in advance exactly what systems, people, processes,modifications, budget and timeline may be necessary as this all comes to pass. The TraceabilityReadiness Analysis allows manufacturers to understand the framework of what needs to bedone and prioritize projects that can be tackled now, regardless of future regulations, and whatprojects will be rolled out as necessary as the regulatory landscape is more defined. A typicalanalysis through full implementation can take 3-5 years. For pharmaceutical manufacturers, it sthe question of How do you eat an elephant? Rather than being overwhelmed or frozen by theenormous task in front of them, a Traceability Readiness Analysis will provide the road map to acustomized traceability solution that provides the much needed business value and return oninvestment 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 youwhere 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.© 2011 PharmTech, Inc. All Rights Reserved