TrackTrace Rx

Month: March 2017

Preparing for Serialization – Focal Points

By No Comments

The Drug Supply Chain Security Act (DSCSA) November 2017 deadline is approaching fast, perhaps too fast for some companies. Even if the largest players have prepared and tested their serialization solutions ahead of time, the industry as a whole is far from being ready on time. Some reports suggest many companies need 12-24 months more to implement serialization; a fraction of the market has not started yet. The latter believe the FDA would postpone the deadline. Should the deadline be postponed or not, serialization implementation is an endeavor of an extraordinary magnitude.

Most serialization projects start out as DSCSA compliance initiatives, but the thing is serialization goes far beyond that. You need a significant budget, personnel and time, new equipment, new IT systems, and new processes. Each of these requires massive investments, but when combined, these ingredients may create a hog in your budget. That is why implementing serialization requires time, from nine months and up, to plan, test, and troubleshoot before the prime time. Inevitably, glitches and setbacks will occur. Preparing right when choosing the serialization solution, as well as working in close coordination with your partners, CMOs, and 3PLs will help you get there.

Data

Careful planning from a forward-thinking perspective will let your serialization solution optimize your operations and even increase revenue. So, the first thing on your agenda should be evaluating in the long-term and short-term perspective your:

  • Compliance needs
  • Scalability capacity
  • Rich data

It is the data that holds the largest potential for boosting your operations, especially the tracking events of a product as it moves down the supply chain. For your data to have value beyond compliance, it must provide tangible benefits, such as your ability to query it and use it for reporting to partners (for DSCSA compliance), facilitating an investigation when the need arises, and solving ad hoc issues in your routine operations.

It is highly recommended to capture all critical tracking events and include the serial numbers involved in the event – the date and time complete with the time zone, location and the operational context (condition of the product, and associated transactions).

The captured pool of data should include:

  • Data needed specifically for the DSCSA compliance (applying the serial number, packing, shipping).
  • Processing of exceptions.
  • Processes that are critical – sampling, repacking, inspection, and others.

CMOs

The ultimate responsibility of serialization under the DSCSA is on the shoulders of the manufacturers, but if contract manufacturers (CMOs) lag with their serialization efforts, the manufacturers are at risk. In other words, CMO lag is manufacturer’s lag, so keeping a close communication loop with your CMO is important. You need to put in place the agreements that cover the key DSCSA responsibilities between your companies. You must have a voice in enforcing your CMOs serialization initiatives, and advising on packaging optimization and supply chain processes.

3PLs

Engage your third-party logistics providers (3PLs) to leverage their serialization capabilities:

  • Define responsibilities, rules and accountability in your mutual serialization efforts.
  • Provide access to master data (GTIN, GLN, and attributes), as it is crucial to identify the key events accurately.
  • Put in place clear governance standards to preserve the integrity and accuracy of master data, especially as it is updated over the course of time.
  • Data requirements must be clear, especially with the current mix of standards. GS1 EPCIS 1.0 of 2007, 1.1 of 2014, or 1.2 of 2016 – the industry is relying on three active versions of the GS1 EPCIS standard. Agree on the data format requirements down to the specific EPCIS versions for data interoperability, especially when interfacing with multiple partners.
  • Work on integrating systems to achieve maximum supply chain visibility. 3PLs’ shipments affect manufacturer’s revenue and inventory directly. Manufacturers need data from 3PLs to send ASNs and invoices, so integrating to their systems lets manufacturers receive timely alerts and act on them, minimizing the wait times. API-enabled technologies grant systems interoperability without time-consuming programming.

Know Your Partner’s Requirements

Drug manufacturers, CMOs, re-packagers, and 3PLs all have their share of responsibility to ensure drug traceability within the supply chain. Every actor will expect to receive tracking events data from their trading partners. Some may be still at the early stages of identifying their data requirements. So, knowing what kind of data is required by your trading partner will save everyone the hassle when the deadline is due. Ask your trading partners about:

  • Specifically what tracking event data they need, and how it compares and scales down to the data you intend to capture. Adjust.
  • What master data you need to synchronize with each of your trading partners (drug name, dose, dosage form, and so forth).
  • What identifiers you and your partner use for product identification and party and location identification (SGTIN, GLN?)
  • What cybersecurity and data protection mechanisms are required by each of your trading partners.
  • What mechanisms you will use to transmit/receive data (to know if you need to support legacy protocols such as SFTP, AS2).
  • What roadblocks can hamper interoperability?

Conclusion

Finally, assess your vendor. See if the vendor is compliant with the GS1 EPCIS standards, or if/how they can ensure the collected data is used effectively to get business insights and optimize your operations. Do they have enough bandwidth (support, engineering capacity) to meet the deadline? Do they work with any of your trading partners (if not, can they interface with your trading partners’ systems)?

You can not go solo in your serialization project. Every actor of the drug supply chain is responsible for their share of the requirements. Manufacturers, CMOs, 3PLs, wholesalers, and serialization solution vendors must collaborate to get it done right. Then it’s good business.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Top Challenges for Serialization

By No Comments

Once the Drug Supply Chain Security Act (DSCSA) is fully implemented in 2023, the industry and the consumers will be able to harness the benefits of a safer supply chain. The patients will benefit because it will be easier to identify counterfeit products in the supply chain and remove them. Drug manufacturers will benefit from the detailed data they can use to support sales or marketing campaigns, optimize supply chain management, enhance performance by CMOs, improve management of the cold chain, minimize losses stemming from product diversions or losses, issue returns credits at original prices, or assess product availability. Other supply chain partners will benefit from serialization, too. To make that happen, however, manufacturers, wholesalers, dispensers, repackagers and other participants must live up to their DSCSA responsibilities.

One of the recent IQPS reports gives an insight into the complexities and roadblocks the pharmaceutical industry faces with regards to serialization compliance. The bad news is serialization endeavors look intimidating, but the good news is there exist solutions that help companies implement serialization as smoothly as possible.

Deadlines

Recently, we reported on a serialization readiness survey that found a part of stakeholders would require another 12-24 months to complete their pilot programs and troubleshoot issues. Some companies have not even started, yet, because they are confident the FDA will postpone the November 2017 deadline. This gives a false sense of security.

The serialization requirements for the November 2017 deadline are clear. In 2015, the FDA granted a six-months grace period for manufacturers failing to meet the January 2015 lot-level traceability requirement. Perhaps, it is for this reason that some companies believe the agency would grant another grace period for the November 2017 serialization deadline. However, the agency might not be so inclined to do it this time because we have known about the deadline for four years now, which is enough time to prepare.

What if you are late?

The more there are companies trying to speed up their serialization implementation at the same time (months before the November deadline), the more solution vendors’ resources will be stretched thin. Some vendors reject new clients, others expand their bandwidth by hiring new staff. The new personnel needs the training and experience to be at par with the more experienced peers.

Needless to say what happens when complex strategies are rushed, and serialization is a complex endeavor. Rushed solutions often lack in the planning part. Hurried planning may not account and future-proof for the otherwise predictable future needs, addressing the nearest goals only. Rushed communication may lead to misunderstandings among your internal staff as much as with your partners. Your internal staff needs ample space and time for training and testing your serialization solution. In other words, if you have not started, yet, you need to do it now and maintain a reasonable pace to avoid these hurdles.

Aggregation

Unit-level serialization is clear, but aggregation is an implied requirement. The lack of an unambiguous aggregation requirement in the DSCSA led some companies to believe they do not need to implement it before 2023, which is the deadline for electronic tracking and traceability.

Even if they are right in theory, they are wrong in practice, given the three largest drug wholesalers (the Big 3) demand aggregation as early as 2018-2019. For them, to make serialization feasible they need aggregation information for trading partner sales.

“As a wholesaling community, we have ~58MM saleable returns a year; if we can’t get data, how will we execute the verification of those products?” says Matt Sample of AmerisourceBergen. Based on average estimates, aggregation implementation takes 30% longer to execute.

Manufacturers that have not included aggregation in their 2017 unit-level serialization compliance plan risk facing production disruptions and extra costs incurred by the wholesalers’ requirements to aggregate.

Challenges Beyond Compliance

The unique serialization codes present another challenge. Creating, managing and coordinating the unique serialization codes for individual drug products across the organization (and during each stage of the production process) requires a standard, interoperable and centrally configurable solution.

Integrating different coding formats is a resource-hungry necessity. So is the integration of your serialization solution with your existing enterprise and legacy systems, as well making it work with your third-party partners such as CFAs, 3PLs, and CMOs.

Pharma companies face the challenges of customer connectivity and significantly larger data volumes, which may have an operational impact. Serialization equipment and implementation of software were the initial concerns of many manufacturers. Now that many companies have made progress in this area, the next roadblock is transforming your serialization pilot into an ongoing business operation. When data exchange is implemented on the packaging unit, we face serial number level challenges between trading partners because the manufacturers have many-fold relationships with others in the supply chain.

Therefore, manufacturers should already be in the process of implementing the following:

  • deploying the necessary systems to create, randomize, and commission serial numbers
  • imprinting serial numbers on unit-level packages
  • transmitting Transaction History, Transaction Information, and Statements
  • planning for incorporation of warehouse operations to record serial numbers during packing and shipping

The packaging line equipment and systems, serial number repositories and control systems, scanning systems and hardware need interoperable interfaces, so there is the technical and financial challenge.

Training staff and establishing operations that include serialization responsibilities is a formidable organizational challenge.

Challenges Beyond The 2017 Deadline

EPCIS data exchange will continue to be an issue because it is new to the pharmaceutical systems and their business processes. Thorough testing of data exchange ensues. Technical, labeling and data related exceptions might persist past the deadline, says Sample.

Serialization Challenges Facing Contract Partners

Contract partners face mainly IT integration testing challenges that imply artwork change in development and qualification, says Christopher Howell of Patheon. Best practices for the CMOs and pharma companies include early testing, frequent communication with all stakeholders and standardizing GS1 requirements.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Upcoming DSCSA Deadlines Explained

By No Comments

Screen Shot 2016-02-22 at 9.59.05 PM

The Drug Supply Chain Security Act mandates the prescription drugs be serialized by November 2017.  However, the DSCSA and other serialization regulations are complex and suggest far-reaching consequences and costly upgrades. To simplify the complexity to a certain extent, we can break down the deadlines in smaller milestones. The Food and Drug Administration program, when laid out in pieces, can help us identify these milestones, and perhaps, even see some hidden liabilities.

November 2017 – Serialization Deadline for the U.S.

Everyone in the U.S. drug supply chain knows about this one, and unless the current administration issues an administrative freeze, or the FDA grants a waiver or delays the deadline, all pharmaceutical companies and CMOs have to deploy serialization full-scale by the beginning of November 2017. Some industry actors rest assured the deadline will be delayed because the serialization readiness is far from complete industry-wide. Nonetheless, eight months from now all prescription medicines aka RX products must be serialized.

Note: all homogenous cases must be serialized, too.

November 2017 – Wholesalers Beware of Hidden Liability

DSCSA, as many complex regulations, has implicit and explicit requirements, and one of such hidden November 2017 deadlines affects wholesalers. Some regulations in the drug supply chain’s DSCSA may be addressed directly to manufacturers, and so manufacturers prepare. However, when we look at how the same regulation affects the wholesalers, we can see the wholesalers are liable just as much. Smaller wholesalers may easily overlook these less obvious deadlines. In the meantime, the said deadline is approaching, and unless you are one of the three big wholesalers you might have missed that one detail.

A case in point – wholesalers’ ability to receive the product tracing information, the so-called 3 Ts (transfers, transactions, and trading partners), in electronic format by November 2017.

The direct DSCSA mandate is for the manufacturers:

 ‘‘(C) ELECTRONIC FORMAT. —‘‘(i) IN GENERAL.—Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, except as provided under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in electronic format” 

Explicitly – for manufacturers, yet implying wholesalers because if manufacturers must send the product tracing in electronic format in 2017, wholesalers must be able to receive the Transaction History, Transaction Information and Transaction Statement in electronic format accordingly. Even though their respective deadline is 2019.

Most big wholesalers have already met this requirement, but the small- and medium-size businesses are still using the paper-based product tracing (packaging slips, invoices).  All pharma supply chain partners, including wholesalers big and small, are liable for failing to meet this requirement after November 2017. This requirement places distributors in a difficult position, and perhaps we might see some regulatory updates requiring full aggregation and transfer of aggregated data long before 2023.

Needless to say, wholesalers have busy compliance schedules ahead:

  • 2017 – electronic product tracing
  • 2019 – trade serialized Rx, verify suspect products by SN ID, returned SN products
  • 2023 – fully interoperable SN exchange, sunset transaction history

2023 – Data Exchange and Full Unit Traceability

By 2023, DSCSA mandates full unit level traceability and data exchange, wrapping up the long journey of DSCSA implementation. Even though the deadline is 2023, the impact on other participants in the drug supply chain can have effects before 2023, just like in the case with 3Ts liabilities.

A Moving Target

In a recent serialization readiness survey, one participant said global serialization compliance is a moving target referring to changing regulations in some countries. The U.S. regulatory climate might spell change regarding DSCSA, too, because the FDA has scheduled to release nine guidance documents. Hence, we might expect some clarifications that might accelerate certain deadlines, or affect trading partners in some other way. Here are the scheduled FDA guidance documents:

  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (for pharmaceuticals without product identifiers that are in the supply chain after the serialization deadline is due).
  • Identifying Trading Partners under DSCSA.
  • Product Identifier Requirements under DSCSA – Compliance Policy.
  • The Product Identifier for Human, Finished, Prescription Drugs (questions and answers regarding SNI and other serialization data, as well as barcode carriers).
  • Standardization of Data and Documentation Practices for Product Tracing.
  • Verification Systems under DSCSA for Certain Prescription Drugs.
  • Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate.
  • Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.
  • Fees Incurred Under the DSCSA.
  • Repackaging of certain drug products by pharmacies and outsourcing facilities.

Four of these were due in November 2015, and when published, they could have a serious impact on how some manufacturers approach the full serialization of prescription drugs deadline in November 2017. The industry is looking forward to these documents. Yet, the FDA has not been overly active since President Trump took office. It could be that the new administration is taking its time to appoint the new FDA Commissioner, but it could also have something to do with the Executive Order enacted by President Trump recently. The agencies now need to eliminate two regulations for every new one. A 60-day freeze was ordered on all new regulations. It could be the case that the FDA guidance documents we are waiting for might be viewed as “regulations,” so the FDA would need to repeal eight old guidelines before publishing at least four new ones.

Until any of these speculations are confirmed, and even if you hope the deadline will be delayed, the November 2017 requirements remain mandatory. Therefore, your serialization implementation strategy must be ready by now. You and your trading partners need to test the solution and have time for identifying issues and troubleshooting if DSCSA compliance is on your agenda.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Serialization Readiness: Takeaways from 2016 Pharmaceutical Serialization & Traceability Report

By No Comments

 

The International Quality and Productivity Center released its 2016 Pharmaceutical Serialization & Traceability report [PDF] aimed to assess the current serialization compliance readiness and the main challenges the pharmaceutical industry has yet to overcome, as seen by pharma and biotech professionals. Small to medium (SME) and large pharma and biotech manufacturers, distributors, logistic service providers, technology providers, hospitals, and training institutes took part in the survey.

Approaches to Planning

Companies adopt one of the four most common strategies to reach complete serialization:

  • 69% – Proactive deployment of global track and trace programs that would accommodate regulatory requirements for all relevant countries, future-proofing the system against compliance updates. Such companies rely on the efficient implementation ahead of time to preserve their market share, gain competitive advantage and profit from serialization through added supply chain visibility.
  • Localized, incremental deployment approach sees companies deploy their track and trace efforts by country due to resource limitations and/or strategic preferences that focus on localized decision making.
  • Many small and medium pharma and biotech manufacturers and virtual entities are just getting started to understand and/or plan for the regulatory compliance and related business requirements. About 24% of respondents are at the initial stages of their serialization projects, where companies outline the required infrastructure, evaluate partners and CMOs.  Some manufacturers in this category intent to outsource their serialization efforts.
  • Finally, the 6.3% minority of respondents report their companies have not started a formal serialization compliance program at all, yet. These companies plan to outsource the entirety of their serialization decision making. Some companies in this group believe the enforcement of serialization regulations will be delayed.

Serialization Implementation Progress

  • 25.7% of respondents said their companies had started serialization rollout across multiple sites globally.
  • 21.6% said their companies were currently looking for solution providers.
  • 20.3% replied their companies were in the early stages of planning for serialization.
  • 13.5% said their companies had started the pilot rollout in one site.
  • 13.5% of respondents said their companies have fully implemented serialization.
  • 5.4% have not started thinking about it, yet.

The late adopters, says the report, face a daunting amount of complex tasks they need to deliver in a short time, with no time for identifying or troubleshooting issues before the deadlines. A total of 47.3% of respondents has not deployed a pilot project, yet.

Challenging Regions

Asia is seen as one of the most challenging regions for planning the serialization strategies. Europe and the U.S. are perceived as the regions with harmonized regulations.  Overall, the number of regulations in different countries presents a major challenge. There are over forty regulations in different countries with varying deadlines from as early as 2017 to deadlines not set, yet. These local regulations are different in complexity and detail, and grasping it all requires significant resources.

Pressing Deadlines

The challenge for the EU and US regions is the highly pressured deadlines, which constitute one of the major roadblocks to serialization compliance. As November 2017 approaches, and the DSCSA requires that all manufacturers implement product serialization, many companies report being late.

11.8% report full readiness, 4.4% need less than six months, 20.6% need 6-12 months more to reach full serialization.

Approximately 40% of respondents need 18-24 months or longer to implement serialization fully, which means the majority of them will likely be late by DSCSA serialization deadline in November 2017.

The EU Falsified Medicines Directive (FMD) is perceived as an arduous process difficult to implement, requiring large, invasive and expensive packaging lines re-engineering. The EU FMD deadline is set for February 2019, and 60% of respondents believe they have just enough time for proper testing of serialization. 12% said the time until 2019 is insufficient.

Implementation Status

33.3% of respondents don’t know how many packaging lines they will need to upgrade in response to serialization. 35.9% will need to upgrade less than 10 packaging lines, 28% – 10-99 lines.

Early adopters add serialization capabilities to most of their lines, sometimes consolidating lines with similar requirements to save on the upgrades in the future as new location-specific regulations emerge over time. Early adopters see significant benefits of serialization beyond compliance. However, the SMEs trail behind in upgrading their packaging lines, and the key reasons are:

  • changing regulations in some countries
  • no clear guidance on aggregation & grandfathering
  • industry standards set by industry leaders, and not the governments
  • hopes the deadlines will be delayed
  • the deficit of resources

The report concludes most global health agencies responsible for enforcement of serialization regulations might have to delay deadlines eventually, as the industry is far from being ready.

Major Roadblocks to Serialization

Compliance is a top concern with regards to the implementation of serialization efforts, as regulations keep changing continuously in various countries. Compliance and integration with third parties such as CMOs, 3PLs and CFAs is another resource-hungry roadblock alongside the cost increase stemming from multi-region compliance efforts.

Optimal use of existing equipment and technologies (41.7%) and integration with legacy systems (35.4%) are among top challenges companies see in their serialization efforts. 10.4% report having issues with cross-site coordination for the serial generation for similar product lines; 6.3% with the creation of unique serialization codes for individual products during production, and 6.3% listed high-speed printing and verification of codes.

Cost concerns revolve around training and associated downtime, and the challenge of fully understanding the serialization costs and potential ROI beyond compliance.

Planning and deadlines are among the main challenges, with some respondents noting the difficulty of implementing track and trace and serialization simultaneously, choosing reliable partners, and adhering to requirements in time. Many SMEs fear that CMOs will not reach serialization compliance in time, which may have serious consequences.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza