Today the PCI Days Fair in Warsaw has started!

After pandemic period, only remote contact and activities we were looking forward for this LIVE event. The reliable team of Mado Systemy has set up a stand full of charm, technical and technological innovations.

We took the task of bringing a large number of machines from our Show Room in Gdańsk, as an example a serialization device with weight control TQS-HC-A-TE, an aggregation device TQS-CP and a HIT our own product MaDos – quality control, vision inspection, cooperation with serialization software.

In addition we are showing software we sell for serialization of drugs, medical devices, quality control, process management, documentation processes, track and trace etc. We invite you to talk, discuss, jointly analyze trends and topics in the area of serialization, aggregation, labeling and product tracking. Only with us, the knowledge provided in a very light and accessible way, the pleasure of discussing and planning new projects or modifying existing processes GUARANTEED.

Sales team UNBELIVABLE, technical team GENIUS.

Came and see. Feel invited. We are looking forward. We act. We share knowledge.

The NEUCA Group is the largest pharmaceuticals distributor and an important manufacturer of such products. As an experienced manufacturer of pharmaceutical preparations Neuca keeps the highest European safety and quality standards, so the products are in pharmaceutical quality.

 

Adjusting its activities to the applicable standards, the NEUCA Group started cooperation with Mado Systemy and Verifarma in the scope of delivery of solutions for serialization of medical products.

 

“After the regulation of serialization imposed by the European Union, we had to expand our offer, just like our customers expected, who wanted to have a one hand provider, and that’s how our relationship with Verifarma began”, points out Karolina Domanska, VP & Development Director of Mado Systemy.

 

Mado Systemy supports companies from the Neuca Group in the field of project preparation and implementation of solutions. The signed contract provides for cooperation over a period of five years.

 

The main challenge was to connect quickly and efficiently with the many NEUCA partners. Due to the number of orders, these companies generate the largest number of serial numbers, explains Mr. Kolankowski.

 

For this task, it was necessary to provide a dedicated device. “After analyzing the requirements, it turned out that in addition to automatic serialization, a manual solution would be required.

 

This additional challenge was solved by Verifarma which meant an advantage for the customer. In this way, it was possible to expand the system without additional charges, ”informs Mr. Kolankowski.

 

NEUCA partners. Some of them were required to generate serial numbers for their own needs. An example would be a small MAH company. “We offered them to buy their own system, but due to the savings they decided to work manually with the EMVO Gateway. Verifarma proposed an XML report compliant with the EMVO format, in order to make it available to the customer via SFTP. From then on, Pharmavitae works like this. We emphasize this case because it is a great example of supplier flexibility ”- emphasizes Mr. Kolankowski.

KEYS TO SUCCESS

“When analyzing the implementation process, we can distinguish three main goals that guided the client” – says Ms. Karolina Domańska: “First of all, the integration of many partners. In this area, it was important to define the number of partners and to propose a reliable solution. The second goal was integration with the ERP system and proper communication, Verifarma rose to the occasion here, we had direct contact with the IT Director, and the answers were immediate. Many teleconferences were carried out and the required support was provided, which resulted in an excellent final solution”- emphasizes Ms. Domańska.
 
In summary, there are several key factors that have made Mado Systemy the preferred vendor and have made this implementation successful. Above all, flexibility during contract negotiations. Addtional key aspect was the ability to adapt to specific customer requirements that appeared after a detailed analysis of the processes. Another important issue was the priority response to critical issues: “In this case, we had long discussions about SLAs and what would happen if something went wrong. I consider it a success that we were able to take quick steps and provide solutions if there was already a problem” – recalls Mr. Kolankowski.

 

Another significant component of our collective success was the fact that we were able to offer a comprehensive one-stop serialization solution for levels L1-L5. “This is an aspect that our clients turn to us with particularly often and it was also crucial in this case,” admits Mr. Kolankowski. It was also important to optimize costs per serial number as well as specialized support with serialization regulations.

 

Looking further into the future, Ms. Domańska sees broad prospects in the relationship between the two companies. “It would be a great honor if we could continue to participate in their development, business expansion and solutions that improve the operational process.”

 

“It was with great pleasure that we worked with competent and committed employees of Mado on the implementation of this project. The company’s activities were characterized by flexibility, professionalism and a comprehensive approach to the implementation of the entrusted tasks. Our cooperation went smoothly, which is why I strongly recommend Mado as a specialist in its industry and a reliable and trustworthy business partner.”

 

– Ilona Idzior-Staniszewska, Project Manager at NEUCA Group

Challanges:

• Integration with many customers
• Requirement to customize the ERP of the Customer so it may integrate itself

Benefits:

• Flexibility during the negotiation of the contract with very fast responses
• Great customizing capacity, inclusive after the project begins
• Priority response on critical issues
• Offer of one hand solution for level L1-L5 serialization
• Reduced cost per serial number
• Specialized support on serialization regulations.

ABOUT NEUCA

The NEUCA Group operates in key areas of the healthcare market. It is the largest distributor of pharmaceuticals in Poland and an important producer. It has the largest number of clinical research centers, develops a network of medical clinics, and is a promoter of numerous startups and innovative medical solutions. Independent pharmacists, whom the company actively supports, are NEUCA’s strategic partners. In order not to compete with them, NEUCA does not have its own pharmacies. By combining key areas, NEUCA has gained a unique position, creating unique opportunities for its clients and business partners. For years, NEUCA has been strengthening its leading position in the independent pharmacies market.

ABOUT MADO

Mado Systemy has 25 years experience in the market and acts as an exclusive representative of well-known global producers of solutions within the field for the optimization of technological lines and quality control devices and at the same time they offer an integral service related to the proper operation of the production quality control for the food, pharmaceutical, cosmetic, chemical, transport and logistics industries. Where Verifarma offers high quality IT solutions for the continuous improvement of the processes and safety of patients. In addition, as from the beginning of year 2018, Mado Systemy acts as a certified reseller to implement Verifarma Track & Trace Solution, the integral service for the serialization and traceability of medicines that helps the pharmaceutical companies to comply in due time with the FMD of the European Union.

You can read more about our comprehensive Track & Trace solutions. Manufacturer’s website – WIPOTEC-OCS.

Feel free to contact us.

Target successfully reached

We would like to briefly describe how the combined teams of MADO SYSTEMY and LEK-AM companies developed as a project team. Goal was a comprehensive implementation of serialisation of medical products in accordance with the requirements of the EU Falsified Medicines Directive (FMD). We’ve covered a four production lines in a modern production plant of LEK-AM.

 

A project of this scale required a partner who had experience in managing the risks associated with implementing the new serialisation processes. Production companies, regardless of their size, put more and more emphasis on production efficiency and the best possible use of the machine park. Maintaining a high OEE index while implementing a new technology requires close cooperation between the supplier and the manufacturer. We were very happy to receive the news that Mado Systemy from Gdańsk was chosen for this project.

 

A dedicated team of qualified engineers was able to carry out a large part of the implementation work remotely, ensuring significant cost and time savings. We spent the consultation period with the client on carrying out independent test projects which were later used for the quick and smooth execution of the order. This resulted in the delivery of a complete solution both on time and in line with the assumed budget. The entire project was also carried out in accordance with the philosophy of the Open SCS Group. Which enables further integration and development of additional functionalities (e.g. in the case of aggregation) without putting the customer in a “vendor lock-in” situation – dependence on one supplier.

What we covered

Comprehensive implementation of the serialization project included:

 

1. Implementation of the necessary Verifarma software, which is responsible for:

• Generating serial numbers for Lek-Am’s own production;
• Generating and sending serial numbers to CMO;
• Receiving CMO-produced serial numbers for Lek-Am;
• Communication with EMVS for serial number status reporting, recall and changes;
• Managing the database of manufactured serial numbers;
• Reporting of serial number transactions;
• Reporting of production operations and storage of operation history;
• Communication and management of own production, sending and receiving orders from production lines;
• GMP compliant event log.

2. Implementation of four TQS-HC-A devices from WIPOTEC-OCS:

• They work automatically with a throughput of up to 300 pieces / minute;
• Managing serialization orders at the production line level;
• Integrated system for weighing, printing serialization data, applying tamper-evident labels and verification of all above.

The process of an end-to-end serialisation solution described above actually works so that for in-house production at Lek-Am, serial numbers are generated in the Verifarma system for the created orders. After generating the appropriate data, it is sent to the TQS serialization lines. Processed orders are stored locally in the machine database. The operator selects the right order and starts production. After its completion and confirmation of completion in the TQS machine, the order is automatically sent to the Verifarma system, where in the next step the responsible person decides to release the batch for trade. After being released in the Verifarma system, the order is reported to the EMVS.

 

„It was with great pleasure that we worked with competent and committed employees of Mado on this project. The solution is user-friendly, employees and operators praise the after-sales support, as well as the work in production. Our success in implementing the serialization process without any delays in the execution of production plans, without creating additional stock, would not be possible without the full commitment of Mado employees”.

 

– Piotr Malanowicz, Director of the LEK-AM Sp. z o.o.

ABOUT LEK-AM

The Pharmaceutical Company LEK-AM Sp. z o.o. is one of the most dynamically developing pharmaceutical companies on the Polish market. Currently, the company employs over 440 people, and this number is gradually increasing. The company’s production plant is located in Zakroczym near Warsaw. The production facilities are a modern pharmaceutical production plant and a laboratory equipped with the highest quality equipment.

 

Production lines and the laboratory operate according to European standards. A team of qualified and professional employees ensures that they are complied with. The preparation methods meet all GMP requirements, and the products for clinical trials are manufactured in accordance with GLP and GMP guidelines. Even today, when planning the production of further preparations, they are gradually implementing the next stages of expanding the production facilities along. Ensuring the necessary technological solutions for serialization in order to ensure the highest quality, safety, and authenticity of their products.

ABOUT MADO

Mado Systemy specializes in comprehensive services related to the proper functioning of quality control in the production process. We cover production of the food, pharmaceutical and cosmetic, chemical, transport and logistics industries. Mado is a family company with 25 years of experience, many projects, also “tailor-made”. We support pharmaceutical companies in the design, installation, integration, and implementation of technologies. Additionally serialization and aggregation processes.

 

We encourage you to contact us and see our Track & Trace devices, and the manufacture;s website – WIPOTEC-OCS. We will be happy to advise you in a specific project.

Just over a year ago since the implementation of the European order against drugs counterfeiting, the industry is still testing its operations to return to the pre EU FMD productivity levels.

What seemed the best solution, it is not so today

In the last 5 years we have seen that many new printing equipment providers and also new serialization software providers have emerged and had no experience at all in the pharmaceutical industry, and even less, in environments regulated by government agencies.

Many companies of the sector have fallen in the marketing illusion and have acquired in many cases very expenses software or printing equipment with performance levels much lower than those required for their current operations.

Likewise, the integration between hardware and software with different providers has not been easy, and if we add the connections with manufacturing contractors or Customers with processes and a large variety of software, the challenge is great. To implement all this new operation has not been easy, but the regulation has required the effort and we had to rush out and comply with February 9, 2019 time period.

But now is time to review what we have really implemented, whether or not it complies with expectations and if it keeps up with our operations at really competitive costs. It is time to return to the pre EU FMD operating efficiency.

Consolidation of providers

Even though it may appear somehow hasty, we already see throughout Europe the replacements of equipment and serialization software providers that have not met expectations. “All-in-one” solutions that have proved not to be the most proper ones for the speed and flexibility that customers need, who are trapped in problems that many times have been reflected in the supply of the product in the market. We have seen also manufacturers of equipment coming from other industries that have tried to take a chance in the pharmaceutical industry and have fallen short or have not been able to adapt themselves fast to high demands.

Finally, as we have mentioned above, many companies have hired novel serialization software providers, that have little experience and who did not have local resources for implementation and support. These providers have relied themselves on alliances with local representatives who, due to the low quantity of customers, have not prospered. In several cases said alliances no longer exist, and the customers have remained alone, with a very deficient operation support.

The same has happened with those companies that hired new software providers with great financial backup and a surprising commercial machinery, but without any experience at all interacting with regulatory entities, what meant for their customers serious operating problems and stock depletion of its products in the market.

That is the reason why, those companies undergoing such situation have started to analyze who are the providers of serialization hardware and software which have prevailed in the market and have measured to the occasion, with high productivity levels, agile and precise technical support and reasonable costs.

We will see then in the next few months a consolidation of the providers of equipment and serialization software in only 3 or 4 alternatives, while the rest will disappear due to the lack of scale.

Return to operating efficiency

The new serialization processes have reduced the operating efficiency, this is a reality. According to an internal report, we have found at least 7% reduction of efficiency in the conditioning process, and in addition to this, the time to prepare impression lines, the remittance and reception of serial numbers, validating that the batches contain all the information to be sent to production, handling at the warehouse of serialized products, among other very different situations.

In large production volumes, this reduction of operating efficiency has a strong impact in the income statement, not to mention the cost of maintenance of the equipment and software which in many cases is excessive and definitively improvable.

We need to return to the pre-serialization productivity levels avoiding a disproportionate impact in the income statement. For the manufacturing contractors, this search of efficiency will become a key competitive advantage at the time of attracting new customers.

Someone to help me

It is essential to keep an ongoing operation, since the slightest interruption in the production process may generate days of delay in our products market entry.

When incidents occur, we need a team of professionals near, that understands our business and process and may furnish us a fast and precise response. That is the reason why we need that the technical support offered by our serialization providers must be local, in our language, with an extensive hourly coverage and with well trained technicians to detect the source of the problem and solve any situation.

In the last 12 months, since the start-up of serialization in Europe, the support has been essential and even more during this stabilization stage. We have seen companies abandoned by its serialization providers, although they have hired what seemed the only and best solution of the market, with the best support.

This will be a key factor to bear in mind at the time of evaluating our current providers and deciding whether or not to continue working with them or changing to look for the excellence in our production processes.

Ariel Romero Díaz
EMEA Head | Verifarma

 

Verifarma software

As in the case of serialization regulations in the pharmaceutical industry, UDI compliance for medical device manufacturers is soon to become a global matter. Following the EU UDI regulations for medical devices and in vitro diagnostic devices, more countries have already issued guidance or a draft of their own localized UDI requirements. Here are just a few examples:

• India requires UDI compliance by January 1, 2022
• China’s UDI requirements will be enforced on October 1, 2019
• South Korea’s phased implementation took off in July 2019
• Saudi Arabia has also drafted UDI guidance
• Taiwan’s FDA issued an Administrative Guidance of UDI at the end of 2015

The International Medical Device Regulators Forum (IMDRF) — a voluntary group of medical device regulators from around the world — strives to achieve a high level of standardization of UDI guidelines all over the world. The aim of a standardized UDI system across global markets is to improve numerous aspects of the medical device and healthcare industry by helping fight against the falsification of medical devices, facilitating their traceability and reducing medical errors.

In this respect, back in 2013 IMDRF issued the UDI guidance document, which served as a base for the US and EU UDI regulations. Despite the common efforts toward high levels of standardization, the UDI requirements of some countries differ from those of the EU and the US.

These differences include but are not limited to the following aspects:

• Types of AIDC carriers required (2D Data Matrix or 1D Barcodes)
• How a UDI should appear on the label or package of a device
• What device types are subject to UDI regulations in different markets
• What data attributes are required in UDI-DI and UDI-PI
• Enforcement deadlines
• Events that trigger a new UDI

Manufacturers must stay informed about the regulation amendments in order to be able to react in a timely manner to any regulatory changes and update their packaging strategy if necessary.

 

WHY DO INTERNATIONAL TRENDS MATTER?

 

Differences in the above-mentioned aspects can have a significant impact on how a UDI system is implemented and used in global markets. This could compel manufacturers to produce inventory that can only be distributed in specific countries or regions.

Manufacturers and packaging companies will need to update their packaging lines to implement solutions that are flexible enough to adapt to the regulations of other countries. In addition, compliance should not come at the cost of the efficiency and speed of the packaging lines. It is, therefore, very important to equip packaging lines with solutions that can maintain high throughput rates.

WIPOTEC is an international leader in reliable machine solutions that enable compliance with global regulations in the pharmaceutical and medical device industries. Our industry leadership is demonstrated in more than 2000 successful compliance projects. As a GS1 partner, WIPOTEC follows global regulatory developments and updates relevant features in its machine solutions to enable full compliance with newly emerging global regulations.

To learn more about the EU regulations, you can download the most recent FAQs by following this link or contact us to learn about the necessary measures for other global markets. We will be happy to advise you on your specific project.

 

We encourage you to contact us and to familiarize yourself with our Track & Trace devices. We’ll be happy to advise you on a specific project.

Source: WIPOTEC-OCS

MADO SYSTEMY TOGETHER WITH WIPOTEC-OCS IS READY FOR SCENARIO WITH A LARGE SIGNATURE CONTAINING 88 CHARACTERS.

Federal Law No. 381-FZ is thereby supplemented with regard to the mandatory labelling of goods for unique identification. A labelling code in machine-readable form, presented as a data matrix code/barcode or recorded in an RFID tag, is stipulated as the identification means. It also lists the definitions for its essential components:

• Labelling code (a unique sequence of characters, consisting of an identification code and a verification code; AI01 GTIN, AI21 SN, crypto code AI91&92)

• Identification code (a sequence of characters representing a unique number of units of goods; AI01 GTIN, AI21 SN)

• Verification code (a sequence of characters generated by the cryptographic transformation of the identification code and enabling the identification of forged identification codes when it is verified using a control data module and/or with verification code verifiers; AI 91, AI 92)

• Verification code verifiers (checking of the authenticity or forgery of the identification code as a result of verifying it using the verification code and the key document for verification of the identification code)

• Technical means for generating a check code – hardware-software encryption (cryptographic) information security tools, which ensure the generation of a check code as the result of a cryptographic conversion of an identification code and for which a security agency has issued a document.

FACTS

Deadline 01.01.2020.

Products that are placed on the market up to the deadline have to be serialised and aggregated, so for imports the regulations must be implemented even before the deadline. As a result, registration, contracts and verification (test) with the system operator (CRPT) must take place in advance.

SPECIFICATIONS OF THE LABELLING REQUIREMENT

Furthermore, Executive Order No. 1556 – “Directive governing the system for monitoring the movement of pharmaceuticals for medical purposes” – of 14.12.18 defines further details concerning the specific appearance and operation of the Russian system for tracking medicines and labelling the packaging of pharmaceuticals. The Executive Order came into force on the day of its publication. Regulations are stipulated for primary (e.g. blister packs for tablets), secondary (e.g. boxes) and tertiary packaging (in the sense of aggregation in shipping cases). Identification means is to be represented as a 2D data matrix conforming to the standard ISO/IEC 16022-2008 with error correction ECC-200. Its grading according to ISO/IEC 15415-2012 should have at least classification C or higher.

The identification means may be applied by printing on the packaging or by means of a label. In conjunction with Federal Law No. 488-FZ, 6 data groups are specified for identification and verification parts which are listed in the following table (Serialisation). In line with international standards and in accordance with ISO/IEC 15417-2013, the aggregation code for consolidating serialised products in a third packaging level for transport and storage is generated in the form of a one-dimensional barcode as SSCC 128. Information contained in the aggregation code can be printed in readable form. The aggregation code can be printed on the tertiary packaging or can be applied using a label.

The process of assigning the electronic signatures and verification keys is carried out in four steps according to the (simplified) procedure shown:

1. The registered pharmacist/distributor sends its generated serial numbers, linked to the GTIN, to the system operator (CRPT)

2. The system operator (CRPT) uses the data received to create the cryptographically generated electronic signature. Furthermore sends it back to the pharmacist/distributor together with the verification key

3. Application of the data matrix code to the products

4. Sending of reports and the data of correctly applied data matrix codes

POTENTIAL FUTURE DEVELOPMENT

In December 2018, the system operator CRPT signalled its willingness to talk to market participants. It may be possible to shorten the cryptographic electronic signature of the Application Identifier (91) which currently has 88 characters (numbers, lower/upper case letters and special characters). At present there is no more detailed official information available about the final number of characters planned. For this purpose, CRPT is carrying out a series of tests with participants of the Russian pilot project. Should a reduction of the AI (91) be possible, it might be expected to take several months until any changes are made to the Russian legislation. This will not alter the deadline for the mandatory serialisation of pharmaceuticals on 01.01.2020.

Mado Systemy together with WIPOTEC-OCS has prepared itself for this scenario with a large signature containing 88 characters. We already have appropriate solutions ready for both existing and new machines.

 

We encourage you to contact us and to familiarize yourself with our Track & Trace devices. We’ll be happy to advise you on a specific project.

Source: WIPOTEC-OCS

How to get ready for European FMD

In less than a year, Europe’s Falsified Medicines Directive (FMD) will come into full effect, starting on 9th February 2019. This definitely implies a massive challenge for those entities in the small and medium side of the industry. But what does this really mean for the companies in pharma distribution?

Smaller and medium-sized companies in the Pharma Industry will have the choice to apply the needed serialization processes through an outsourced partner. This process, however, can take several months. Therefore taking action promptly is recommended to be able to market these products before the directive comes into place.

Small Pharma Companies

“Small and medium sized Pharma Companies needs agility and cost-effective solutions to remain competitive without compromises in their operation. That’s a big challenge when the countdown is running.” concludes Ariel Romero Diaz, Verifarma Head of Sales for EMEA.

The main issues for this part of the industry is the master data management and data exchange. Especially with contract manufacturing organizations (CMOs). For them, a solution familiar with a lower volume of production and specific target markets makes way for a quicker solution to sort through aspects such as traceability and FMD compliance.

Manufacturers should also be aware that delays in their serialization process without proper professional guidance could result in direct effect to the lines or production. From packaging lines to warehouses in pharma distribution. Many of them assume that the practice impacts only the first ones. However it demands many changes in automation and data handling. That cannot be changed in such short notice, affecting several aspects in departments such as IT, engineering and logistics, among others.

Acquiring a specialized and previously authorized partner for managing your products’ EMVO data is extremely recommended. As it will have enough time to process, therefore successfully avoiding any future issues in your production lines or track and trace solutions. To be sure to get enough time, the best choice is to go through a partner with working knowledge of both track and trace and FMD compliance. So, consequently will make the serialization of your products a quick and painless procedure to adjust your products to the new EU measures.

About Verifarma

Verifarma is a comprehensive and flexible Track & Trace solution for the pharmaceutical industry with more than 10 years of experience, optimized deployment processes and an unbeatable price. Our know-how on regulation is key to help you meet legal compliance on time. As a result achieving prompt adaptation to regulatory changes while applying best practices and industry standards. Verifarma is an active member of Open SCS Working Group.

With active deployments in 15 countries, over 2,000 companies in the pharmaceutical industry rely on Verifarma for Serialization Levels 3, 4 and 5. Among leading Pharmaceuticals, Distributors, 3PLs, Pharmacies and Health Care Centers.

 

Please take a look at our Track & Trace and software solutions.

 

Source: Verifarma