FAQ from Wholesale Distributors

These questions were asked at our Certification Course in collaboration with Life Science Training Institute:
LSTI Course: Key Elements of Pharmaceutical Serialization and Implementation 

 

FAQ from Wholesale Distributors:

Listed are all pending compliance requirements, including the Salable Returns.

 

  1. How does DSCSA apply for distributors?
Nov. 27, 2019 Accept only serialized product Wholesalers may engage only in transactions of products encoded with unique product identifiers, which will be used to verify a drug’s legitimacy and enable product tracing in the event of a recall or the identification of a suspect product.
Nov. 27, 2019 Match original transaction information with returned products that will be resold. Wholesalers may accept returned products for resale only if they can associate the returned product with the original transaction information and transaction statement for that product.
Nov. 27, 2019 Verify unique product identifier of suspect products at package level. Wholesalers must verify the product identifier, which includes the standardized numerical identifier, or SNI, for products they suspect are potentially counterfeit, diverted, or otherwise unsafe.
Nov. 27, 2019 Verify the unique product identifier of returned products intended for resale. Wholesalers must verify the product identifier, including SNI, of returned products intended for resale.
Nov. 27, 2023 Participate in electronic package-level traceability system Wholesalers must exchange transaction information and statements in an interoperable electronic manner, and the transaction information must include product identifiers. Wholesalers must put in place systems and processes for electronic package-level verification and provide traceability information to regulators to permit access to a drug’s full distribution history when investigating a suspect.

product or during a recall.

 

 

  1. Explain grandfathered products: Can they be sold? What do they mean? 

    RELATIONSHIP TO “GRANDFATHERED” PRODUCTS UNDER SECTION 291 582(a)(5) OF THE FD&C ACTThis compliance policy addresses products a manufacturer introduces in a transaction into commerce without product identifiers between November 27, 2017, and November 26, 2018. In the future, FDA intends to issue additional guidance that will outline FDA’s current thinking on the “grandfathering product” provision of section 582(a)(5)(A) of the FD&C Act regarding products not labeled with a product identifier that are in the pharmaceutical distribution supply 298 chain at the time of the effective date of the requirements of section 582. In that guidance, FDA intends to address the relationship of the compliance policy set forth in this guidance with “grandfathered” products.DSCSA non-enforcement draft guidance

The full compliance policy still hasn’t been published, as it’s going through review as a draft to accept challenges, recommendations and a critique (the comment period closed in January). The primary reason for seeking further guidance dealt with enforcement of DSCSA, specifically with regards to manufacturers applying serialization to products. The deadline for compliance here remains Nov. 27 of 2017, but in the draft the FDA states they will not enforce the manufacturers’ product identifier requirements under the DSCSA for another full year. While this buys some manufacturers, wholesalers, and repackagers some more time, it begged the question about what “introduced in a transaction into commerce before Nov. 26, 2018” meant.

Specifically, from lines 37-41 of the draft guidance:

‘In brief, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogeneous case of products intended to be introduced in a transaction into commerce before Nov. 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers.’

What does that mean? A less conservative approach might assume that as long as the batch is released before Nov. 27, 2018, then there is no requirement for compliance, even if shipping that product after the deadline. The more conservative approach would have meant to consider each and every product individually. Fortunately, the November 2017 Grandfathering draft guidance clears this up.

The Grandfathering draft guidance specifically states (from lines 122-124):

‘For the purposes of this guidance, a package or homogenous case of product is “in the pharmaceutical distribution supply chain” if it was packaged by the product’s manufacturer before November 27, 2018.’

The key word is “packaged”. Any product “packaged by the product’s manufacturer” before the deferred compliance enforcement date (November 27, 2018) will be exempt from enforcement of DSCSA requirements for affixing a Product Identifier. Subsequently, this draft guidance exempts any trading partner requirements relating to Product Identifier as it relates to product supplied by a manufacturer if that product was packaged by the manufacturer before November 27, 2018 without affixing a Product Identifier to that package or homogenous case. This includes the following:

 

Exemptions for Product Packaged by a Manufacturer without a Product Identifier before 11/27/18:

  • The investigation of suspect product, that is verifying product at the product level using the Product Identifier (this applies to manufacturers, as well as their downstream trading partners).
  • Wholesaler requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2019.
  • Dispenser requirements that they engage in transactions involving only product encoded with a Product Identifier beginning November 27, 2020.
  • Repackager requirements that they accept ownership of product encoded with a Product Identifier beginning November 27, 2018.

However, it is important to understand what is not exempted.

 

Not Exempted (for any manufacturer or downstream trading partner):

  • There is no extension of compliance dates for the requirements for investigation/verification of product at the package level using the Product Identifier Product packaged by a manufacturer (or repackager) prior to November 27, 2018 that has had a Product Identifier affixed to its labeling.
  • There is no exemption from the requirement to validate any applicable transaction history and transaction information in their possession and otherwise investigate any suspect product to determine if it is illegitimate.

 

And specifically, for repackagers:

  • If a repackager wishes to transfer ownership of a package or homogenous case of product without a product identifier on or after November 27, 2018, it must first add a product identifier to the package or homogenous case of product. Basically this is saying that all product packaged after November 27, 2018 must be serialized (have a Product Identifier), regardless if it is packaged by a manufacturer or a repackager.
  1. What are the penalties if you don’t follow DSCSA?

As of this moment FDA didn’t announce any penalties.

  1. What products don’t need to comply with DSCSA? 
  • Blood or blood components intended for transfusion
  • Radioactive drugs or biologics
  • Imaging drugs
  • Certain IV products
  • Medical gas
  • Homeopathic drugs
  • Lawfully compounded drugs

 

We appreciate your feedback and would like to know how else we can help. Please send your questions or comments about “FAQ from Wholesale Distributors” here.

 

About Life Science Training Institute (LSTI)

FAQ from EU Falsified Medicines Directive Webinar

14 Questions/Answers from the EU Falsified Medicines Directive Webinar with rfxcel serialization expert Mark Davison.

 

What is the role of a Wholesale Distributor in the EU Falsified Medicines Directive (FMD)? How does Falsified Medicines Directive require Wholesale Distributor to function? Do Wholesale Distributor need to integrate to HUB / National Systems?

A: Wholesalers integrate to National Medicines Verification System (NMVSs).
Only Good Manufacturing Practice (GMP) licensed parallel traders, who need to change the box and hence the code, would use the central EU Hub.

 

For products in Phase 3 research, when do you recommend getting ready for serialization for Falsified Medicines Directive ?

A: It is worth having the conversation with your CMO early. If CMOs have already equipped production lines, then the Marketing Authorization Holders (MAH) software part will take around six to nine months. Work backwards from planned launch date by at least a year to be safe.

 

Below what level of annual turnover do you think that corporations will not engage in this process and drop their Rx-bound activity?

A: We have seen some very small companies contemplate that step. Below about 50,000 annual units produced, it is hard to amortize costs – except for high value products.

 

What happens when MAH issues serial numbers in bulk to CMO, is it possible to track the reconciliation?

A: The rfxcel track and trace software automatically manages the issuing, reconciliation etc. between your software and the CMO, even if they ask for a buffer stock of numbers in advance.

 

Is decommissioning accepted at packing line level?

A: Yes. Until product data is uploaded to European Medicines Verification System (EMVO) (which must be at or before QP release of the product) any data manipulations are fine as long as they are tracked and auditable.

 

Is there any penalty foreseen in case a corporation or country is not ready on time?

A: Apart from reputation and embarrassment, I don’t see how a country could be penalized. For corporations, it is simple. No codes, no sales.

 

Where is the legislation in regards to NMVO contracting?

A: The countries of the EU are at different states of readiness. Some NMVOs are running pilots and getting people connected, others are not yet fully set up. The fee and contracts for those connecting to them are not specified in the FMD and are at the discretion of the NMVO.

 

How ready are pharmacies?

A: Not very, in most countries.

 

Does MAH Level-4 system needs to exchange the data with CMO Level-4 or Level-3?

A: In the case of rfxcel, both are possible. Typically, it would be between Level 4 systems.

 

For the EMVO on-boarding process:

What title/function is generally seen and/or expected as the Single Point of Contact (SPOC) within an organization?

A: Can be anyone but should be the person able to answer and deal with queries etc.

What role/function generally handles the registration/on-boarding within an organization—Regulatory, Supply Chain, Commercial? Is this is the same as the SPOC? 

A: Varies by company. Someone must sign as a legal designate of the corporate entity (i.e. senior person) but the onboarding can be done by anyone.

 

Where can I go to get more information on the on-going/annual fees associated with MAH per country? 

A: https://emvo-medicines.eu/mission/emvs/#countries

 

I’m getting management pushback backed by external counsel, that there is no legal foundation to join NMVOs. Do you have one example in national legislation of stated requirements?

A: EU Directive 2001/83/EC, Article 54a/2/e (as amended by the provisions of Directive 2011/62/EU, commonly known as the Falsified Medicines Directive) says that the cost of the repositories system shall be borne by the manufacturers. In the UK, the Falsified Medicines Directive is transposed as-is through the Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] which came into force on 20 August 2013.

 

Will Brexit make any difference?

A: In my opinion, no – for a couple of reasons.

The immediate timing of the FMD will be before Brexit, and with the 20-month transition time that is built in, this will allow the UK to carry on with any rules which are to be enforced during that period. So, for at least 2 years after the FMD, Brexit will have no effect, by law, on FMD enforcement.

The UK is such a large manufacturing country; I would be astonished if they diverge away from the rules that apply to the rest of the EU Union.

 

Do you think that the FMD could be delayed, similar to the DSCSA delay by the FDA?
A: No one knows the true answer to that. However, it could be quite possible if we are nearing the 2019 deadline and a sufficient number of organizations are not ready. With that said, I would not want to be the guy who has to explain to his superiors that we chose not to prepare ourselves, as we were counting on a delay that did not occur. We now cannot sell product for 6 months and need to take that time to catch up. My suggestion would be to not bank on it.

 

Will everyone be ready on 2/9/19?

This is the largest IT project in recent years; nearly 30 countries and the entire pharmaceutical supply chain is involved here. The chances of absolutely everyone being ready on day 1 are nil, but we all need to make our best effort to do everything we can to help this process be the best it can. It won’t be perfect, but it will be a whole lot better than what we have today.

 

Listen to the full webinar here.

Or copy/paste this link in your browser: https://www.rfxcel.com/webinar-eu-falsified-medicines-directive/

DSCSA Compliance

The United States has been taking initiatives to discourage the introduction and distribution of counterfeit drugs. With that goal in mind during November 2013, the Drug Quality and Security Act (DQSA) was introduced. DQSA is a federal framework to address supply chain security. The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.

The DSCSA compliance laws aim to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:

  • Enable verification of the legitimacy of the drug product identifier down to the package level
  • Enhance detection and notification of illegitimate products in the drug supply chain
  • Facilitate more efficient recalls of drug products

Serialization for the US is centered on the Standardized Numerical Identifier (SNI). The SNI is a national registration and serial number for the medicinal product and each pack. Each unit must also carry the lot number and expiry date as a mandatory requirement. All data is a 2D data matrix code and printed on the pack. The serialization data are reported to the parties involved so that the flow of goods in the supply chain can be re-traced.
rfxcel Traceability Platform is designed according to the internationally accepted ANSI/ISA S95 standard. Meaning, an efficient track-and-trace solution should integrate with the packaging equipment, line controllers, and Central Repository via standard interfaces for seamless communication. This architecture ensures seamless information exchange in both directions. It is flexible enough to catch errors before unacceptable product accrue. For example, production can be stopped in instances of missing or inconsistent data to avoid manufacturing unusable (i.e. incorrectly serialized) products.

The DQSA affects:

  • Manufactures
  • Wholesale distributors
  • Repackagers
  • Third-party logistics
  • Pharmacies

DSCSA compliance implementation phases
Lot-level management
Started on January 1, 2015, for manufacturers, wholesalers, and repackagers, and July 1, 2015, for pharmacy (hospitals and retail): Share the 3T’s: Transaction Information (TI), History (TH), and Statements (TS) at the Lot (or Batch) level of identification.

Item serialization
Mid-term (2017–2019): Manufacturer/repackagers serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® (GTIN®) or NDC), serial number, lot number, and expiration date.

Serialized item-level traceability
By November (2023), make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or repackager.

DSCSA COMPLIANCE REPORTS
The DSCSA compliance transactions or changes in ownership includes the following elements:

1. Transaction information (TI)‐includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number,
transaction date, shipment date and the name and address of the businesses previous and subsequent owner.
2. Transaction history (TH)‐ an electronic statement that includes the transaction information for each prior transaction back to the manufacturer.
3. Transaction statement (TS)‐electronic confirmation by the entity transferring ownership of the product.

Each business is required to provide the TI, TH, and TS to the subsequent owner for each transaction. Each party, buyer or seller, must capture and maintain the TI, TH, and TS for each transaction for six years.

Transaction statement confirms that the product is authorized under the DSCSA compliance laws and received the product from an authorized party.

  • TI and TS from the previous seller are received
  • Shipping only legitimate product
  • Systems and processes to perform verification
  • Did not knowingly provide false transaction information
  • Did not alter the transaction history

How can rfxcel help?
With over 14 years in the traceability business, rfxcel understands the need to fulfill these regulatory requirements. Pharmaceutical and biopharmaceutical companies need a reliable track-and-trace solution to have a strong process workflow.

rfxcel provides the following solution requirements:

  • DSCSA compliance with international anti-counterfeiting requirements
  • Support of GS1 labeling information
  • Management and randomization of serialization numbers in operations
  • Management of modular aggregation for item, bundle, pallets
  • Integration with centralized track-and-trace repositories
  • Verified product that is EPCIS certified
  • Handling of packaging orders and batch information
  • Dialogs to create, discard, aggregate, and disaggregate units and hierarchies
  • User management, including rights management & audit trail
  • Recording and reconciliation of used and unused serialization numbers

The industry trusts rfxcel Traceability Platform for its scalability and reliability. rfxcel meets the needs of serialization, DQSA compliance requirements, business value and competitive advantage.

rfxcel Traceability Platform offers:

      • rfxcel Integration Server – an integration engine to merge external systems with rfxcel products. These external systems can include ERP Systems (e.g. SAP, Oracle, IBS), Packaging Systems and Edgeware (e.g. Optel), Country-specific Drug Data Repositories and more
      • rfxchange – the ecosystem that connects formatted and mapped data to DQSA hub and any other global repository
      • Data processing and validation ensures no bad data gets into the hubs
      • Scan: scanning capabilities, shipping, receiving
      • Seamlessly data exchange and formatting for DSCSA requirements
      • Collaboration and integration with all partners, customers, and other solution providers
      • Works with multiple file formats (XML, SAP iDoc, PML, EDI, or any custom data types and file formats)

Contact us for a 20-30 minute demo.

Complete Understanding of the EU Falsified Medicines Directive

The EU Falsified Medicines Directive and What It Means

Europe’s Falsified Medicines Directive (FMD) comes into full force in little over a year, on 9th February 2019. Far-reaching, mandatory requirements for product coding, traceability and tamper-evidence will be enforced in over thirty countries.

What is the Requirement?

The FMD requires that all unit-of-sale packs of prescription medicines (with potential exceptions for perceived low-risk products) must carry a “safety feature” comprising a Data Matrix code and human readable data, and must be tamper-evident.

The code must contain a minimum of four pieces of information: batch number, expiry date, global trade item number (GTIN) and a randomized serial number. Some countries require a fifth data string for national use. The data must also be printed in human readable form, ideally adjacent to the code. Manufacturers (and licensed parallel traders) will code their products and report data to a central EU Hub run by the European Medicines Verification Organisation (EMVO). This will push data down to appropriate national data repositories run by corresponding National Medicines Verification Organisations (NMVOs). Pharmacists (or other authorized persons) will scan the codes during the dispensing process and these codes will be checked against those local databases.

Who Must Report FMD Data?

The task of reporting accurate data to EMVO is the responsibility of the Marketing Authorisation Holder (MAH) and cannot be delegated to a contract manufacturer (CMO). This means that every MAH company, however small or virtual, needs a software solution to generate, manage and report serial numbers in a highly accurate, controlled and validated way. This comes as a surprise to some companies, who are used to outsourcing everything, but it needn’t be a major burden given the right solution choices.

How Should Companies Report Their Data?

However the serialisation data is generated, whether by in-house software or by an outsourcing partner, the data will need to be collated and uploaded by each MAH. All serialisation data from such license holders will go through EMVO and their hub system. This means that early engagement with EMVO is important. The administration procedure to register with EMVO as a MAH involves a number of documentation steps and verification checks. It is not a quick process and can take months. Over two thousand MAH entities will need to be on-boarded to EMVO in 2018, which is likely to lead to a bottleneck. We recommend that MAHs start the process now rather than wait until later in the year.

What Tools Are Needed for Reporting?

This challenge cannot be addressed with an Excel spreadsheet and the IT equivalent of duct tape. Too much is at stake. The FMD should be seen as a significant business continuity risk, albeit with upside potential. The law is very clear: no data or wrong data means no sale. This means that license holders can’t afford to delay or to choose the wrong solution.

Production lines need to be modified with code printers, vision systems to check printing, ejection mechanisms to remove miscoded packs, perhaps more-stable conveyors, tamper-evidence stations etc. These are controlled with software, classified as Levels 1-3 on the ISA-95 scale. They pass data to Level 4 (enterprise-level) and Level 5 (external reporting interface) software. These last two are sometimes combined into the same solution, as with rfxcel, and provide the gateway to the outside world.

Only a small number of gateway solution providers, including rfxcel, are currently Technically Certified to provide access to EMVO. This certification is a critical minimum requirement, which indicates that the software solution has been rigorously tested and shown to do what EMVO requires. But that doesn’t mean it has been optimized for data quality. Don’t assume that all certified vendors take a proactive approach to data integrity. In most cases, the system is validated but not the data flow within it. The old adage of “garbage in, garbage out” still applies. Look for a vendor that actively checks the data fields for accuracy. Not just one-time validation of data connections but checking every piece of incoming data for errors. Also beware of systems that require frequent re-validation due to external changes beyond your control.

What About Distributors and Dispensers?

When manufacturers upload their data via the EMVO hub, it is then pushed down to national repositories run by national medicines verification organizations (NMVOs). This is done based on the master data attributes and specifically the global trade item number (GTIN). For example, data for products destined to be sold in France will be pushed to the French NMVO. Any downstream checks by distributors and dispensers are made against the national repository in their jurisdiction.

Unlike the equivalent US law (the Drug Supply Chain Security Act) the FMD doesn’t require codes to be checked between manufacturer and pharmacist except on a risk basis (e.g. for returned product). However, pharma logistics in the real world is complicated and bi-directional. The FMD is likely to increase the flow of returned product, at least until the system stabilises. In the same way that implementing serialization causes an overall equipment effectiveness (OEE) impact on production lines, the FMD will cause a macro-scale “OEE” dip in the European supply chain.

Is Aggregation Mandatory?

Aggregation is a production process that builds a hierarchy of traceability data from pack to case to pallet. One master code on the outside of a container is linked via a database with the identities of all the unit packs inside. This means that one scan can verify multiple codes in a sealed container – very useful for distributors and for managing internal hub and spoke logistics. Aggregation is not mandatory under the FMD, but avoiding unpacking, checking and re-packing coded product during verification is one of the key reasons that many MAHs are implementing aggregation.

Summary

If you have internal production lines and have not yet started converting them for serialization, my advice is to transfer production to a CMO or arrange post-production coding. You probably don’t have time to complete a production line conversion before February 2019.

Every MAH (even a virtual one) needs at least the Level 4/5 software discussed above, since they have the responsibility to report their own data in a reliable and validated way. They must show the regulators that they are in control of their serialization system at all times, so choice of vendor is critical.

If your company already outsources finished goods production, you still have time to procure, install and validate a L4/5 software solution but you need to start now. Call us today for a more detailed discussion and let us help you to get ready for February 2019.

 

Conclusion:

Understandably, this presents a challenge to your company to implement. It is crucial that your company acquires a working knowledge of the law in order to understand your risk. Most companies outsource this work to a solution provider such as rfxcel. rfxcel is a EU FMD compliance software provider that addresses all compliance management and requirements, serialization processes and connectivity to a global network. With hundreds of customers and over 14 years of experience, rfxcel has been the leader in the track and trace industry for pharma. A company focusing on the success of its customer, it ensures a designated team for your implementation, support and quality control.

 

What is Serialization?

What is Serialization?

Serialization is the assigning a product identifier to each product item to be tracked and traced to its location in the supply chain. A serialization code can be as detailed as a customer or government regulation requires and can include the manufacturer’s Global Trade Identification Number (GTIN), product description, stock-keeping unit (SKU), lot or batch number, expiration date, date of production, and line and plant in which it was manufactured.

Why Serialization?

Compliance:
Changes in regulations by leading bodies such as US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for finished prescription products. Pharma companies across the globe are need alter their practices to comply with regulations and anti-corruption laws. Until now pharmaceutical companies have been battling counterfeit drugs. These challenges have been from improper branding to hiding safety information and not following quality manufacturing standards. This caused regulators to add more laws and procedures to help protect consumers unsafe drugs.

Value Beyond Compliance
1. Brand Protection – Serialization helps protect consumer safety through proper labeling management of packaging processes. This can help protect brand reputation by increasing patient safety.
2. Visibility in the Supply Chain – Manufacturers can capture necessary information while a product moves through the supply chain. Companies can improve efficiency, control costs, and increase shipping accuracy.
3. Increase Profits

How to serialize
1. At the pallet level – wholesaler
2. At the multipack level – wholesaler/retailer
3. At the single pack level – hospital pharmacy level

Serialization with rfxcel
Our 13 years of experience implementing serialization and track and trace solutions enables us to offer excellent service in projects undertaken for customers. With well-integrated technologies and systems, rfxcel is ready to reap the continued benefits of Track & Trace and deliver similar capabilities to its partners.

Flexibility in a partner
To succeed in serialization, solution provider should be flexible and understand the customer’s environment to customize a solution to fit. A serialization solution is never “one-size-fits-all” because every company is different. The right partner will offer track-and-trace capabilities and software components designed to address requirements for the pharmaceutical industry, and can customize the offering for virtually each track-and-trace project addressed.

To learn more why we are different click here.

Private Cloud for Compliance Requirements

Understand how to meet compliance requirements with a private cloud module.

 

So you’re thinking of buying a cloud-based serialization L4/L5 solution. You’ve read some marketing materials and maybe the idea of a shared network appeals, because you know another company who’s using that system. Before you write the purchase order, read on.

Who will validate your cloud-based serialization system?

Under the rules such as 21 CFR Part 11 and EU GMP Annex 11, YOU are responsible.  You can use vendor tools, templates and widgets but no-one else can sign-off on the quality for you. Therefore, whenever the vendor system changes you need to react.  You remain responsible for your own data quality so every change is a risk. Think about what risk assessment and validation burden you are prepared to accept, before you choose your vendor.

How often do you need to re-validate?

That depends on your tolerance for risk. Shared cloud, multi-tenant systems inherently change much more frequently than private cloud, single-tenant solutions. They have to adjust to continuous demands from all the companies using the shared system. If a change made by your shared cloud service provider could impact your business processes and data quality, you must conduct a risk assessment process.  Colleagues tell us that running that process every week or two gets tedious. If there are major changes then you may need to fully re-validate some or all of your data connections more often than you’d like. Furthermore, on a shared cloud, this will not happen at a time of your choosing but will be driven by the vendor’s considerations.

 

Is there an easier way?

Private cloud solutions, like those provided by rfxcel, don’t have the same issues.  We give you your own software instance, within our secure cloud environment.  In our model, your validated system remains locked down until you decide you want to update it.  You can roll multiple patches and updates into one change event, and schedule any IT resources you need well in advance. Private cloud architecture doesn’t mean you’re not linked to the outside world. We provide a cloud-based exchange server which is used by hundreds of entities. We routinely exchange data with all of the major system providers on a daily basis, so you’re not locked out of your CMOs or logistics partners, even if they made a different choice.

 

Data integrity means checking not assuming

Don’t forget that mistakes happen, even in validated systems. It may surprise you that some of our competitors don’t check data. They assume that what comes in is correct, and pass it on. We make over fifty checks on data fields to ensure that even if something goes wrong you’ll spot it before an error becomes an incident. The cost of a recall is usually more than a million dollars, so make sure you give yourself every chance of avoiding one caused by a serialisation error.

  

Contact us today to see how rfxcel can help you to be compliant without unseen validation burdens and data quality risks.

 

Verification Router Service for Manufacturers and Distributors

A challenge in the pharmaceutical supply chain is accurate and timely verification of serialized saleable customer returns. According to the Healthcare Distribution Alliance (HDA) member survey, saleable pharmaceutical returns comprise 2 to 3 percent — or nearly 59 million units — of total sales annually. HDA and industry leaders are working on solutions to reduce these losses and help manufacturers and distributors to fully comply with DSCSA by 2023.
Currenly, HDA and industry experts are testing  the verification process of  returned products that are saleable. rfxcel is an active member of the “Work Group” formed by HDA to develop an integrated solution such as a Verification Router Service (VRS) Provider. The Verification Router Service community is comprised of Requestors, Responders, VRS Providers, and a Governance Body. rfxcel is piloting its VRS in early 2019 in order for wholesalers/distributors to meet DSCSA requirements by November 27, 2019.

 

The Proposed Saleable Returns Process is as follows; a wholesale distributor (Requestor) captures the product identifier information and passes the data to a qualified routing service (VRS), which references the associated GTIN or GCP to automatically query the appropriate Manufacturer’s (Responder) database and return a response in real-time. The Requestor is responsible for passing the appropriate product identifier data elements to the VRS. The VRS is responsible for maintaining and looking-up the appropriate repository information of the Responder and submitting appropriately formatted request message to the repository. The Responders are responsible for providing repository connectivity information to the VRS and providing appropriate responses to the verification requests by matching the product identifier received from the Requester with the product identifier in their repositories.

 

In this scenario, rfxcel is providing the tools manufacturers and distributors need to work together. Only through collaboration they will meet DSCSA compliance in 2019 and 2023. It is crucial for solution providers to have a flexible system that enables them to work closely with customers and their partners to meet compliance deadlines. Within the track and trace pharmaceutical industry, it is important to remember that there is no ‘one-size-fits-all-situation’ to meet DSCSA or other global compliance deadline and requirements. Each company that rfxcel works with is different. rfxcel  works closely with manufacturers, distributors, wholesalers and dispensers to determine their needs and build a product that is best for their company.

 

As the pioneer and leader in track and trace solutions for the Life Sciences industry, rfxcel has developed a highly scalable platform for supply chain visibility, anti-counterfeiting and compliance. rfxcel takes measures to give manufacturers and distributors a flexible solution for an efficient and secure supply chain as the industry continues to work toward full unit-level serialization (2023).

 

For more information send us a message at Contact Us.

 

 

 

Blockchain Technology in Pharmaceutical Supply Chain

Interview with Ramana Pinnam, Director of Product Management, about blockchain technology in the pharmaceutical industry

Perhaps you have heard tale of the up and coming technology called blockchain. Maybe you are an expert on blockchain technology and how it fits into the world of pharmaceuticals. Or perhaps you are like most of the world and you are unsure about what to make of blockchain and frankly you are afraid to ask anyone to explain. If that describes you, never fear! We recently had a fantastic opportunity sit down with Ramana Pinnam, Sr. Director of Product Management here at rfxcel,  after he presented at the 2017 HDA Traceability Seminar. Hopefully this conversation sheds as much light on blockchain technology as it has for us.

 

Could you give us a brief overview of blockchain technology?

Absolutely. Blockchain technology almost says it all in its name. Imagine the “block” as a piece of data and the chain is where that data hooks into place with all the other “blocks” of data. This is a very basic understanding of this technology. The idea behind blockchain technology is to create a secure online based and shared ledger of sorts. Like a banker would keep a ledger of all the transactions by hand, blockchain takes a certain category of transaction and locks in the data so it cannot be lost or misplaced. Blockchain in regards to supply chain has been used primarily in crypto currency transaction such as Bitcoin, but now we are seeing larger companies like Walmart using blockchain to keep detailed records of some of its food products. It is increasingly important in our world today to be able to efficiently track products and transactions from creation to when it reaches the consumers’ hands. Blockchain technology creates a very efficient avenue for that, and we are seeing some pharmaceutical companies beginning to investigate how it can apply to our industry.

 

Speaking of pharmaceutical companies, how does blockchain technology relate to the pharmaceutical industry?

Well, as of now it does not directly correlate or relate. Some companies are partnering together to research and decide if blockchain technology will be utilized as the future for tracking all individual medications and products manufactured by pharmaceutical companies. It seems to be a promising technology to incorporate into tracking products and mitigating risk of loss or counterfeiting of pharmaceutical products.

 

What are some Pro’s and Con’s about adopting blockchain technology?

The largest con right now is that we just do not know for sure if blockchain technology will do what we need it to do. A lot more testing needs to be done in the pharmaceutical industry. One of the main pros is also a con. Blockchain locks in data so it cannot be changed or altered. This is quite a positive when trying to track products, but user error can make this problematic. That is why appropriate education and training will be needed for those who adopt blockchain within the supply chain.

 

If you could, what type of timeline would you guess at for the full incorporation of blockchain into our industry?

As I said earlier, a lot more testing and research must be done. I am not sure of a specific timeline, but there are companies and organizations turning over rocks as we speak to see how blockchain can fit into the pharmaceutical industry. These things take time, but if the research and testing comes back promising we could see the full integration of blockchain technology in just the next few years.

 

After speaking with Ramana Pinnam we all felt a lot more confident in our understanding of blockchain technology. We hope that we at rfxcel can help you feel more confident about all trends in technology and pharmaceuticals. As far as blockchain technology goes, we are always committed to utilizing the best resources available for our clients. As more information becomes available about the application and use of blockchain technology into our industry you will be the first to know about it.

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their solution enables companies to protect patients and meet their compliance needs, while getting insights and visibility into their supply chain. Their relentless commitment to customer success and continuous innovation ensures that companies meet their requirements and protect those who depend on them.

 

Blockchain technology in pharmaceutical supply chain

 

rfxcel at HDA Traceability Seminar

rfxcel is a HDA Traceability sponsor and partner

As the industry works toward the law’s 2023 finish line, HDA’s annual Traceability Seminar brings together healthcare supply chain leaders. These seminars provide the opportunity for industry leaders to collaborate and learn more about upcoming DSCSA implementation milestones. rfxcel is a proud HDA partner supporting their mission and members. rfxcel’s efforts to bring collaboration between companies is showing effective results. rfxcel’s partners and customers enjoy dramatic reductions in costs. They also see improvements in speed, service levels, and successful integrations. These results are tracked across the pharmaceutical supply chain.

This year rfxcel is part of HDA’s Traceability Seminar to educate the industry about best practices of serialization and compliance. As well as, innovative approaches and lessons learned working with distributors, manufacturers and dispensers. Strategic planning, collaborating and a flexible systems are set to implement serialization and traceability technologies. This effort further preserve the safety and security of the healthcare supply chain.

rfxcel is among key DSCSA solution providers for serialization, compliance and traceability. As DSCSA and FMD deadlines are approaching, rfxcel is partnering with manufacturers and pharmaceutical companies to provide them a simple, fast and reliable solution. A flexible and customizable system can meet these requirements. Pharmaceutical manufacturers in the U.S. will reach a major serialization milestone on November 27, 2018. European companies will reach these deadlines with the FMD on February 9, 2019.

This is why rfxcel participates and supports HDA, fellow supply chain colleagues, federal and state regulators, and industry traceability experts to provide details on the progress toward this milestone.

If have question about the serialization process and how to start please contact our team. We are here for you and your success. Please take a look at our whitepaper “7 Secretes of Serialization“. Our teams comes from strong backgrounds is this industry and we want to share best practices in serialization.

Importance of Time Management in Customer Service

Effective time management and a sense of urgency bring better customer service

My father emphasized that all events are a function of timeJust as our lives are bounded by a start and end date – all activities that occur in between also have a time-sensitivity.

This lesson has a big impact on me and drives a sense of urgency in everything I do:

  • Meetings are succinct
  • Discussions are to the point
  • Schedules are managed.

I want to bring this sense of urgency to the new Customer Success  team at rfxcel.

Our 60 day implementation plan is the result of our consistency and planning. Our implementation teams are strong in setting standard artifacts, processes and industry best practices.  This ensures that we deliver value in the shortest time possible to our customers, partners and with other vendors.

We ensure to meet customer’s deadlines. We review customer progress on a weekly basis with rfxcel’s executive leadership.  If projects are behind schedule we examine them in details. Our team prescribes action plans to meet every task. And if needed, we allocate additional resources to help meet the target dates.

For a smooth and worry free transition we developed a Hyper Care Support Team to complete the implementation process. A Hyper Care process overlaps the efforts of the Implementation and Support team. This ensures proper knowledge transfer and rapid response during the critical go-live period.

I look forward to sharing our new service offerings with you and showcasing our Full Service Approach.  Just like our new implementation processes, this message is short and to the point – less than 250 words.  My father would be proud. 🙂

Sincerely,

Vikash Pushpraj

SVP, Professional Services, Cloud Ops & Customer Success