Pharma serialization — challenging months ahead
When the EU Delegated Act (2016/161) on safety features of medicinal products was published in Feb 9, 2016, one would have assumed the industry to be already in full work to get ready by the deadline. This was actually true for the big pharma. Companies having 100+ pharma packaging lines just had to begin work well in advance to have any chance to meet the deadline. The small and medium-sized (SME) manufacturers have been another story.
In August 2018, European Medicines Verification Organization (EMVO) announced that only 841 pharma companies had at least initiated the process to connect to the European Medicines Verification System (EMVS) by signing the agreement with EMVO. This was up only from 500 companies last February, so for most of the about 2240 marketing authorization holders there is a lot left to do. Everyone won’t meet the deadline.
With the big pharma in line as also most of the middle-sized companies, a great majority of the production capacity will be serialized and connected to EMVS in time, thus most drug production will not experience regulatory problems. Some of the small manufacturers producing essential and difficult to replace special medicines may not compliant by the deadline, resulting in a danger of medicine shortages. On the other side, small pharma manufacturers of generics will be in serious trouble if not compliant in time.
I am not a lawyer, but to me it seems that the Falsified Medicines Directive (2011/62/EU, ”FMD”) leaves overseeing the compliance of the pharma manufacturers to the member states. The penalties for non-compliance should be ”effective, proportionate and dissuasive” and ”not be inferior to those applicable to infringements of national law of similar nature and importance.”
It looks to me that this will make many a lawyer happy in the following years.
As an automation integrator with special skills in implementing pharmaceutical serialization, Servicepoint has seen the surge of requests for quotation from SME pharma manufacturers. To respond to the rapidly rising demand we have been recruiting and training more personnel for the specialist tasks. We are happy to help new clients, too. With the current high demand, spending time in tender processes is not a priority, however.
Russian regulatory developments
The Russian pharmaceutical traceability law is going forward with a deadline just eleven months after the EU FMD deadline. The technical specs are still evolving, but case-level aggregation is required by the law for the full traceability service. This should be noted by European manufacturers who, in addition to supplying the European market, export medicines to Russia.
On technical level, the tentative Russian specification spells some trouble for packaging lines. The requirement (see post by Dirk Rodgers) to include a 4-character key (Application Identifier 91) and 88-character encrypted signature (AI 92) to the data matrix, in addition to the (possibly) standard 14-digit GTIN-14 (AI 01) and 13-character serial number (AI 21), results in 122 characters (includes field termination characters). This is considerably more than the 60 digits enough for the EU FMD -compliant data matrix (about 70 with national reimbursement number), resulting in quite a large data matrix (36×36).
Why would this be trouble at the packaging line? As the standard, easy, way to print the data matrix and human readable information is a 12,7 mm wide inkjet printer head, there is a limit how large a square data matrix one can easily print. Making the dot size smaller is possible, but the smaller the dot size, the more difficult (i.e., expensive) it is to reach the required print quality.
Summed up, it sure looks we are going to have an interesting working year ahead, with lots of work needed for the pharma industry to be compliant. Following the regulatory developments is of paramount importance, especially as the Brexit is looming early next year, too.
Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!
Servicepoint Oy — the reliable partner for the manufacturing industry
Serialization and data integrity in pharma production
With the US, European, and Russian pharmaceutical serialization deadlines looming, the industry is busy implementing these new technologies to their production lines.
Serialization, in effect, expands the digital dimension to production data. Instead of just master and batch data, there will be individual package-related data in cloud and ERP systems. Even the small-scale production sites that have been able to rely on paper-based reporting have to adopt digital reporting.
Of obvious importance is the need to reconcile data, not just materials, after the production run before the batch is released. The approved batch should not have serial numbers hanging loose, nor packages without serial numbers, nor serialized packages not accounted for. All the rejected packages with serial numbers must be accounted for.
Digital accounting makes the control of data integrity both easier and harder. On the other hand, the data systems can be made to provide audit trail every data read, write, and change, require digital identification of persons responsible and provide backups. On the other hand, people are prone to looking for shortcuts, especially during incidents. For example, if the person having the access rights to production line stop mitigation is not always close, the personnel may find a shortcut, e.g., having access keys are available at the production line to make quick changes and repairs. This results in obvious data integrity risks.
Data integrity might look like a simple issue with a modern computerized production control systems, but it is hardly so. There are interfaces between the systems: within the organization, between trading parties such as API manufacturers or CMOs and MAHs, and between the MAHs and cloud systems or government repositories, such as the European Hub in the EMVS, and MDLP in Russia.
Each data transfer contains a possibility of unintentional data changes. Guaranteeing the data integrity between ISA levels 2 (production line) and 3 (site/factory level) may well be troublesome if the software solutions on these levels are from different vendors. An example of an unintentional change of data was with HIV testing at a blood service years ago, where the transferred testing data was truncated and critical information lost — leading to people being given contaminated blood.
Compromising data integrity compromises also patient safety.
Data integrity is also related to the data being safe. The serialization data is particularly sensitive as a data security breach may result in counterfeit manufacturers copying the genuine codes to the counterfeit products. The MES and ERP systems should thus be safe from external hacking, even in case the criminals get inside help.
One such case where the serial number data was compromised was at a software manufacturer which, in essence, sold serial codes packed in carton packages, the software being freely downloadable but requiring the license keys. In this case, counterfeits quickly emerged in the market with perfectly genuine, but copied, serial codes. After an investigation, it was found that the issue was not computer system hacking nor an inside job, but the CD-ROMs containing the serial codes were thrown into normal garbage cans after use, and were thus available to somebody outside the factory looking through the garbage for CDs or other data-containing media.
Web links on machine-readable QR or DataMatrix codes create novel data integrity threats. An obvious problem is that the actual content of the web link is not visible, but attack links can also look similar to genuine ones. A malicious link may lead to a fake website made to look exactly like the genuine one and thus lead to a compromised test of product authenticity — it may even contain a trojan/virus attack to the mobile phone reading the code! If web links are added to QR or DataMatrix codes, one should add a layer of security, such as Systech UniSecure.
Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Greece. Call us, we can help you!
Servicepoint Oy — the reliable partner for the manufacturing industry
Countdown to Russian pharma serialization
Servicepoint has been closely watching the developments of the Russian pharmaceutical serialization. As the Federal law on the circulation of medicines has now been approved, signed by the president, and published Dec 29, 2017, it is time to wrap up the developments so far.
I have been covering the development during the design and pilot phases of lawmaking with articles and blog posts, as well as an interview last December.
Summed up, the law is about quite normal serialization, but with a boosted track & trace with extra functionality for the government. The government wants to use the system to watch at pricing and availability of drugs around Russia and provide the consumers a possibility to use a mobile app to search which pharmacists have the drug they are looking for and check the prices, too.
The data matrix should contain, in addition to the normal GTIN (Application Identifier AI=01), serial number (21), batch number (10), and expiry date (17); imported medicines require also a TH-number (240), which is the four first digits of the TN VED (ТН ВЭД), namely 3001 (e.g. blood products such as heparin), 3002 (blood or serum), 3003 (medicines not packaged in dosage forms), or 3004 (dosage forms).
Mikhail Murashko, who heads the Federal Service for Surveillance in Healthcare has stated that he wants implementation for certain drug classes by the end of 2018.
Aggregation is thus required. Official deadline is Jan 1, 2020, but earlier deadlines for the seven high-spending disease classes (7 ВЗН, such as treatment of haemophilia) and medicines on the list of vital and essential medicines (ЖНВЛП, comprising about 40% of medicine packages or 35% of value), are most probably getting earlier deadlines that will be (soon?) decided by Roszdravnadzor (Federal Service for Surveillance in Healthcare). Tamper evidence is still in the air, depending on later acts.
The government also wants to have some visibility to the industry readiness. They are going to set up a working group to monitor the implementation and is going to call for hearings in July 2018 to review the progress. I would assume there will be further reviews as the deadline draws closer.
Several of the European manufacturers who have done minimal implementation of serialization just to comply with the EU FMD needs (serialization, tamper evidence, and data upload to repository), have now found out that they need to do further investment to aggregation. This is all well if the original system has been purchased and implemented so that adding aggregation is feasible and cost-efficient.
Servicepoint has collected a wide experience in packaging automation projects as well as machine vision and inspection systems. We offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Greece.
As we are a Finnish service provider located near the Russian border, we are able to travel to Russian customer sites easily, most of our field engineers have long-term visas. We can also travel on short notice, as in addition to flying to Russia, we have easy train connections to e.g. St. Petersburg and Moscow area. We have Russian-speaking personnel, too. Call us for professional help!
Servicepoint Oy — the reliable partner for the manufacturing industry
The many faces of traceability
In common discussion on pharmaceutical serialization, track & trace means traceability of medicines from the manufacturer to the patient to ensure product authenticity.
On the other hand, the companies employ ERP systems for traceability of products and their components from sources through the logistics to gain supply chain visibility. This is very useful in case there is a defect in a sourced component: broken semiconductor components for electronics, spoiled food sources. Traceability makes product recalls easier and more precise.
This is also the case when products in the supply chain take a diversion. Let’s discuss the European pharmaceutical market under the Falsified Medicines Directive (FMD). This diversion could be an acceptable one, like a wholesaler selling a shipment of products to another wholesaler or a parallel importer (”grey imports”). In a the more complicated supply chain the purchaser of a shipment is required to verify the unique identifiers of the products. Repackaging products breaks the visibility, but the repackager is required both to decommission the unique identifiers of the original product and commission new unique identifiers to be tracked.
An unacceptable diversion would be when a product shipment, e.g. a delivery truck, is stolen. This breach must be detected and the unique identifiers reported to the EMVO as stolen ones to prevent re-entry of the unique identifiers to the supply chain. Why so? The contents of the stolen packages may have changed or new packages might have been produced with copied codes but unsafe contents – or the cold chain may have been broken.
Traceability is about protecting the consumer
For food products, traceability is also viewed the other way round: the consumer wants to know and be sure where the ingredients of his food product originate from. Thus, producer-identifying timestamps on eggs, names of farms in meat products. This process is for the end customer to identify the sources of food products, but not for authentication. The data can be easily copied or falsified.
Some pharmaceutical track & trace plans include a similar possibility for the patients: e.g. the Russian concept includes a phone app that the patient can use to trace back the logistics chain of the specific product to the manufacturer.
In comparison to the agricultural products, the pharma track & trace models do not include information before the manufacturer of the final product, or marketing authorization holder. There is some discussion about visibility to the APIs and excipients included in the medicines, though.
For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of a thousand production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!
Servicepoint Oy — the reliable partner for the manufacturing industry
The patient as the last node of a secure pharma supply chain
One of last week’s news in Finland was the police warning about street sales of Rivotril, a benzodiazepine illegally used recreationally for narcotic purposes. At least one of the purchasers has been taken to hospital for losing consciousness. The sellers have been reported to be ”beggars on the street”.
Fake drugs are a grave threat to health: they may contain, instead of the suggested medicinal ingredient, other harmful or even poisonous substances. Also, authentic drugs that have been diverted from the legitimate supply chain may be a health hazard: the criminals do not care for the proper storage conditions: cold chain may have been breached and even durable medicines may lose potency if left in an overheated car in the sun. Medicinal packages may also have their contents exchanged to similar looking, but totally different pills.
To protect the public, health regulators have taken action around the world, such as serialization and addition of tamper-evidence packaging. With these measures, e.g. the European patients should have their prescription medicines authenticated by the pharmacy in the sales process. The protection given by serialization is not perfect but gives a good final safeguard.
All the investment to pharma supply chain security is in vain if the people take the shortcut to shady sellers of illegal drugs.
Illegal internet pharmacies, masquerading as operating from credible countries and with professionally made websites, give an impression to people to be a shortcut to prescription medicines. Some men, for example, who are too shy to ask their doctor to get erectile dysfunction pill prescription, see direct internet sales as an easy and discreet option. The websites are easy to find. The problem is, they do not check one’s prescription and thus the precautions for existing health conditions or medications are not taken. The other problem is that they do not usually care to sell authentic products as fakes are cheaper.
If the customers ever find out that the drugs are fake, they are shy to report to police as they should not have been purchasing the drugs illegally in the first place. Another problem for the police is that finding the perpetrators is notoriously difficult online.
In illegal online sales of prescription medicines, the risk to the customer comes in two ways: the health risks of digesting fakes, and giving one’s credit card details directly to criminals.
The pharmaceutical industry is investing heavily to implement serialization and track & trace technologies to their production lines. So are the pharmacies and the logistics companies. All this investment is in vain if the people take the shortcut to shady sellers of illegal drugs, for shame or to get medicines that are not appropriate to them.
Another issue is authenticating the medicines bought from internet pharmacies, as the patient has no visibility to the point-of-sale verification; a case for a mobile app with connectivity to the data repositories.
Photo: Helsinki Police Department, Finland
Securing pharma supply chain for the patients
8A recent simulation pilot — by St. James’s Hospital (Dublin, Ireland), Systech International, and Sharp Packaging Solutions — tested the logistics of medicines from the manufacturer to a hospital with test ”fake” products mixed in. The simulation consisted of three batches of cancer medicines each secured by different means: one using the European Stakeholder Model (ESM), another using the US Drug Supply Chain Security Act (DSCSA) model e-Pedigree, and the third using the proprietary Systech UniSecure solution. 50 ”fake” products with unique identifiers copied from the authentic ones were randomly mixed into batches of 500 products each, simulating a breach of logistics security. It was found out that of 50 ”fake” products, 18 got dispensed to the patient before warning signs in the ESM model, and 10 in the e-Pedigree model. This was because in a case the counterfeiters have genuine codes to copy, either because of an information system breach or by copying the codes from authentic products (e.g. in a warehouse), the first product with an authentic serial number will get passed to the patient, even if it is fake.
A fake drug with a copied unique identifier reaches the patient, if it passes the logistics chain before the authentic drug.
Systech UniSecure adds a very efficient layer of security by detecting specific measurable characteristic patterns within the printing noise, harnessing these variations to generate an electronic signature. This electronic signature is unique to a given instance of a product and can be utilized on either a serialized or non-serialized product. These variations are both random and unique, producing e-Fingerprint that is impossible to replicate. As UniSecure does not interfere with the serialization track and trace regulations, it can be readily applied whenever the industry has the need. The logistics partners, pharmacists or even the patient can then authenticate the product with a phone app, which uses the camera existing in virtually all smartphones.
This brings us to another example of problems with the ESM or e-Pedigree: the internet pharmacies. Authentication at the point-of-dispense is all well in traditional pharmacies as the patient can see the verification to happen. In internet pharmacies, this is not the case. The patients should, thus, have a means to authenticate the products themselves, but the government-regulated systems do not allow that, the incoming Russian drug traceability system as an exception. One must remember, that an unscrupulous villain can fake the point-of-dispense application, too, to sell fake products at a criminal-run pharmacy. Systech UniSecure provides for these cases, too, as the industry can opt for extra protection: enter a ”pharma brand app”. This functionality can readily be a part of mobile health app providing also other functions, such as assistance for medication adherence.
Another group that is not yet covered by the government-regulated anti-counterfeiting method nor have a system of reliable pharmacy network are people of the undeveloped countries. A prime example are antimalarial medications: a recent study found 1/3 of antimalarials in sale in Africa were fake. Another survey by WHO in Nigeria in 2011 found that 64 % of the antimalarials were fake (mPedigree). Smartphones are becoming ubiquitous in undeveloped countries. The pharma manufacturers could, then, provide protection for the poor patients, too.
For the pharmaceutical industry, we offer services of an experienced full-service packaging, device assembly, and serialization and track & trace automation integration company. With experience from 30 years in the pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization projects. Call us for professional help!
Product authentication in food & beverages industry
The growing number of food fraud scandals has alerted the consumers, industry, and regulators alike to address the problem of counterfeit food. Virgin olive oil can be fake, pesticides or fertilizers can be counterfeited, and cheap milk quark can be turned to genuine looking mozzarella, to name a few cases.
The food production chain is a complex and delicate construct of seeds, pesticides, fertilizers, fodder, veterinary medicine, logistics, food additives, food processing industry (e.g., dairy, bakery, brewery), up to supermarkets, open market places, and restaurants, to name a few of the parts of the supply chain. There is a multitude of access points where counterfeit products can get in. Business losses are severe and widespread when the public gets alerted. Traceability of ingredients and products should be a priority.
Thinking of the fragile and complex food supply chain, one would assume that anti-counterfeiting technologies would be widely used. On the contrary, the business has been content to rely on trusted suppliers — sometimes even being happy to take in a cheaper alternative from a less reliable source. It is time for the food & beverages industry to adopt traceability.
As food is consumed by people, they should be exactly as interested in the authenticity of the products as they are with pharmaceuticals. Digesting poisonous ingredients is exactly as harmful if supplied within fake food or the same amount of fake medicines. Less of a health problem, faking normal food products as organic may also lead to substantial brand damage.
Anti-counterfeiting measures and traceability should be top priorities to the food & beverages industry for both consumer safety and brand protection.
On the contrary to the heavily regulated pharmaceutical industry, there is no centralized serialization system available for authenticating products on different parts of the supply chain. There are industry solutions available, such as Systech UniSecure fingerprinting technology, which provide product traceability and full authentication with cloud services and mobile apps.
With Systech UniSecure, the product is serialized and the intrinsic noise of printing changing data, e.g., batch & expiry date or a serialization code, is captured with a vision inspection system while the quality of the print is checked. The cloud service enables a mobile phone app that, e.g., the consumer, farmer, or food manufacturing company can use to authenticate the product, be it an end product, pesticide, or a food ingredient, respectively. The technology does not alter the design of the product nor is reverse engineerable. As the technology allows for a mobile phone app, even the consumer can be engaged to authenticate products.
For food, beverages, and agricultural industry, we offer services of an experienced full-service packaging, handling, and authentication automation integration company. With experience from 30 years in the food, beverages, and pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole automation projects. Call us for professional help!
Global running regulatory deadlines for pharmaceutical serialization are putting heavy pressure on the production & packaging as well as IT & QA people in pharmaceutical manufacturers and automation integrators alike. Implementing serialization is relatively easy if one has ample room and financial resources to build a new end for a production or packaging line, but many production sites are not so spacious. Often it isn’t financially feasible to replace all of the old equipment, either. Thus discussion about retrofit serialization installations.
Machinery manufacturers are happy to sell new machinery. Installing new machinery to replace existing ones is also quite a straightforward project, given enough room. When there is a case for retrofit engineering, i.e., installing as little new equipment as possible, more automation engineering skills are required. An experienced automation integrator is able to help the pharmaceutical manufacturer through this project, by pointing out the possibilities and providing the skills needed.
At an old manufacturing site, most or all of the space is already booked by the existing production and packaging equipment. There may be little room for any new machinery. Adding new functionality to the packaging line may thus need a custom design to retrofit due to spacial constraints.
If the production is not already 24/7, there also may be a possibility to unite two production lines with a common packaging end. This helps control the costs to make it financially more feasible to upgrade the level of automation.
In some cases, much of the packaging work is done manually, especially in small-scale production. In some countries, there may be an attitude that with the low local employee costs, automation would not make sense. When a new process phase is introduced, e.g., serialization and aggregation, the situation may change profoundly. As in one of the sites I have visited, there were 8 people at the end of the production line packing the medicines to cartons with leaflets, and then adding the cartons to cases and sealing them. When serialization and aggregation is brought to the same table, even when done manually or semi-automatically, there will be several issues that affect the production economy:
- The more people, the more manual or semiautomatic serialization, and aggregation stations, thus higher equipment cost.
- The new process step might make the job unfeasible to the current personnel given the production line output. There might thus be a need to add more people, and thus possibly even more new equipment.
- The new process step increases the risk of human errors.
- There might not exist extra space for the new personnel in the current packaging room. Adding extra room may be expensive or require difficult reorganization of other production rooms.
In this case, the solution might not be to add extra people and tear down the outer wall of the factory building to build more room. The most feasible solution might be to add an automatic cartoner and then have fewer people, maybe two, with semiautomatic case aggregation stations. No need for an extra room then.
For custom and retrofit production line upgrades, services of an experienced full-service automation integration company are thus required. With experience from 30 years in the pharmaceutical industry, and of 800 production & packaging line upgrades or new installations, Servicepoint can help you throughout the whole serialization and automation projects. We have experience with various retrofitting projects. Call us for professional help!
Serialization workshop: helping you to kick-start your project
Serialization is not just a machine to install, it also requires management software up to the ERP level and connection to the cloud services, such as European Medicines Verification System (EMVS), and to logistics/warehouse companies. The production line may also need an upgrade to facilitate the serialization process. As many clients need help already in pre-project phase, in making the User Requirements Specification (URS), we provide consultancy services and serialization workshops for pharma industry.
With the US serialization deadline for pharmaceuticals looming in the coming November and the EU deadline in two years, the pharmaceutical industry has hands full of work. The developments in China, Brazil, and Russia add to the workload.
The big pharma is generally well into the projects, with roll-up of serialization on line after line. Consultants have been employed and dedicated personnel at serialization software and hardware providers reserved. The medium-small pharma as well as CMO industry has also woken up. Some of the medium-sized enterprises started their projects in a good time, but many are only now looking for help.
A cross-functional steering team is needed
The complexity of the pharmaceutical serialization projects means that a cross-functional steering team is needed: RA, QA, IT, production, factory management, as well as artwork design management. A C-level project owner is needed to keep the project at top priority.
The markets that the products are supplied to must be assessed. Even if the market is European Economic Area (EEA) + Switzerland only, there are regional differences, apart from the obvious language requirements, that need to be heeded. Some countries, such as Germany, France or Spain, may require the national reimbursement code, some have other quirks: Finland, for example, will continue to require the Nordisk Varenummer (VNR) number which is somewhat similar to the reimbursement codes, only not in the Datamatrix, but on the product package.
A serialization solution that has been well-tested in the industry is needed to ensure that all the necessary regulations are adhered to. One must also note that the division of medicines into the Rx and OTC varies between countries, and is subject to change. There may also exist local blacklists of OTC drugs requiring serialization.
The best serialization strategy for you
Servicepoint offers consulting services to define the best serialization strategy for you and to implement your automation and serialization projects. We also closely monitor the development of legislation in the European Union, Russia, and other markets to be able to guide you through the relevant serialization regulation.
In serialization workshops we provide project leaders and stakeholders a solid background on regulatory serialization requirements, industry experiences on serialization and best practices, as well
as help in drafting the user requirements specification (URS).
For the past 30 years our core business has been to design, manufacture and install & integrate new and to retrofit existing production lines
— as well as maintaining them.
We provide you also with an overview on how a serialization project usually proceeds, from your perspective. As an experienced integrator of automation systems, we can provide you with the background needed to make informed decisions from the packaging line hardware up to your ERP system.
We can also assess your production lines, the products and their market areas, your customers’ needs, and the applicable regulatory requirements to produce first order investment cost estimates valued against the profitability. We can also evaluate your packaging lines, and prepare draft plans on where and how to retrofit the serialization equipment and how to upgrade the packaging lines for extra capacity.
More resources for you to concentrate on your core business operations
We do, however, much more than consulting. For the past 30 years our core business has been to design, manufacture and install & integrate new and to retrofit existing production lines — as well as maintaining them. Therefore we can carry out the whole serialization project for you. With the help of our multi-skilled serialization team, you can concentrate your resources on your core business. Give us a call and book us for a workshop — let’s kick-start your serialization project!
Meet us at Pharmapack 2017, February 1‒2, Paris, Pharm Connect, February 22‒23, Budapest, or CIS Pharmaceutical Forum, February 28 ‒ March 1, Moscow.
Give us a call and book us for a workshop — let’s kick-start your serialization project!
Next workshop will be in 1.3.2017 in parallel to CIS Pharmaceutical Forum. Read more
Serialization and Pharma Logistics
When discussing the serialization requirements of the EU Falsified Medicines Directive (FMD), pharmaceutical manufacturers and repositories are most often in the spotlight. The logistics chain has less coverage. The implications of the FMD on the logistics chain are considerable, however.
Let’s first discuss the most obvious: risk-based verification. The supply chain is required to check the authenticity of those medicinal products which are at higher risk of being falsified. This applies to returns as well as to medicinal products distributed by persons who are neither the manufacturer nor a wholesaler holding the marketing authorization nor a designated wholesaler.
Fake medicines in the legitimate supply chain
A prime example would have been the one of Swedish parallel importer in October which lost its license to operate after it had, assumedly unknowingly, passed a shipment of fake HIV medicine to a German wholesaler (news). Even though the means by which the Swedish parallel importer had acquired the falsified medicines has not been published, they probably originated from a source which should have triggered the risk-based verification. Also, the German wholesaler should have verified the products if the EU delegated act on safety mechanisms would already be in force. With the European Medicines Verification System (EMVS) in use, these falsified medicines would have been stopped before reaching the pharmacists.
Serial numbers in ERP systems
Good Distribution Practices (GDP) and FMD imply requirements also on the logistics operators. Controlling the cold chain, managing recalls and damage control in case of cargo thefts all require exact knowledge on which unique medicine packages are where. The Marketing Authorization Holder (MAH) is required to retain records of every operation he performs with or on the unique identifier on a pack of medicinal product for at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution, whichever is longer. The MAH, parallel importer or distributor is also obliged to indicate in the EMVS repositories that a product is recalled, withdrawn or stolen. One must also remember that in the case the shipping unit will be shipped outside the European Economic Area, or when there is a need to destroy expired products, the owner must decommission all the unique identifiers in the EMVS.
ERPs are a ”hidden part” of the European Medicines Verification System
The manufacturer, Contract Manufacturer or Packager (CMO/CPO), and marketing authorization holder need thus to, in addition to sending serial numbers to the EMVS, keep track of the serial numbers and possible aggregation in their ERPs and so need the logistics operators. The other workaround will be to update the information on the medicinal packages on the EMVS — risk-based verification alone will not suffice. How else can one know which specific medicinal packages with unique identifiers were in a stolen vehicle? For this, they will need a standard such as Electronic Product Code Information System (EPCIS). This hidden part of the European medicines verification system is not even mentioned in the EU FMD or the delegated act. Reminiscent to the US DSCSA, the operators in the pharmaceutical logistics thus will need to exchange serial numbers between their ERP systems when transporting drug shipments. Some drugs, e.g., opiates, also have a lucrative illegal market, and drug theft possibility at different points of the supply chain, up to the dispense to the patient in a hospital, must be considered. This has implications also on the security of the linked ERP systems.
Supply chain visibility
As Dirk Rodgers pointed out in his blog, the participants of the logistics chain will, also, have need for other status changes for the unique identifiers than just decommissioning. Expired, stolen or recalled medicines require their own operations in the ERP systems. As long as a drug package exists somewhere in the supply chain — the legitimate or the illegitimate — the manufacturer needs to keep a record on this status. As Mark Davison pointed out early November, the recent WHO guidance on testing of fake drugs recommends naming the ”stated manufacturer” of the fake drug. Fast and easy track & trace to enable fast response is, thus, of paramount importance to a pharma brand.
Serialization facilitates better supply chain visibility. For the manufacturers, knowledge on where exactly the medicine packages are makes recalls easier. Dealing with stolen shipments will be easier. There are some open questions, however: should the manufacturer get to know if its medicines become repackaged or shipped outside of the European Economic Area (EEA)? The delegated act only states that the stakeholders should only have ownership of and access to the data they generate when they interact with the repositories system. Without this knowledge, the serial numbers in the manufacturer’s ERP would become ’ghosts’ in the cloud, even when the unique identifiers are duly decommissioned in the EMVS by the repackager.
How will this all be possible without aggregation? It is not impossible to disassemble a pallet and read all the serial numbers one by one, but that is overly laborious and expensive (see my earlier blog post). The data exchange between the logistics parties is not covered by the EU FMD nor the delegated act. Use of EPCIS standard is strongly recommended to facilitate cooperation of the different parties.
New services for patients
As the serial numbers will exist in the manufacturer’s and, possibly also, in the pharmacist’s ERP, they will be able to engage the patients and provide them with new services, e.g. phone apps to improve adherence to medication. The pilot project of a phone app for hemophilia patients of St. James hospital in Ireland serves as an example of future possibilities. The proposed Russian drug monitoring system (my blog post and news) seems to provide some interesting mobile-phone-based services, too, such as supply chain visibility for the patients receiving the medicines.
We at Servicepoint are happy to help pharmaceutical manufacturers and packagers as well as logistics companies to upgrade their production or packaging lines or warehouse automation to comply with the existing and incoming regulations. We always keep a keen eye on the developments in the regulations – for the benefit of your business.