Global security in the supply of medicines
In effect as of 9 February 2019: From this key date onwards, all prescription medications must carry what is known as a unique identifier (2D data matrix code incl. serial number) on the folding box, which must, in addition, be sealed with an anti-tampering device before they can be put into circulation in the EU. This is aimed at preventing falsified medications from reaching the legal supply chain. Before the product is given to patients, pharmacists, for example, will be able to verify the authenticity of the product by scanning the serial number.
Counterfeit medications are a global problem. According to Interpol, around a million people die every year due to falsified medications. It is also estimated that around 30 percent of pharmaceutical products sold in developing countries are counterfeit. The EU Falsified Medicines Directive (FMD) attempts to protect medications from falsification and to remove counterfeit products from legal supply chains. But in the first instance this has presented manufacturers with the challenge of making their production lines compliant with the new law in terms of both the hardware and software used. In the healthcare segment Arvato offers special machines, powerful IT systems and intelligent processes to produce millions of randomised, alphanumeric serial numbers, apply them to the medication packaging and include the data when tracking goods movements. This creates an end-to-end solution.
IT that makes medications forgery-proof
Arvato IT experts have developed the “Corporate Serialization Database” (CSDB) solution to prevent counterfeit drugs as far as possible. With this software, serial numbers can be generated, managed and fed directly into the production systems of contract manufacturers or packaging service providers, where they can then be printed onto the vials or folded boxes for the medicines. The CSDB can be used to control not just a few production lines, but can actually be used site- and company-wide! Acting as a Certified Gateway Provider, Arvato transmits the serial numbers used to the national verification systems via the EU hub (e.g. “Securpharm” in Germany). This allows the authenticity of the medications to be checked in each pharmacy. The software also enables communication with all participating companies, as well as with other production sites.
“By February next year, all EU countries must have set up a database system that allows the authenticity of medications to be verified on national level,” explains Marius Blomeier, project manager at Arvato SCM Solutions. The CSDB includes all master and serialization data for each medicine.
The manufacturing process: More than just a code on packaging
The SCM department at Arvato is very well prepared for serialization requirements: The healthcare site in Harsewinkel has its own machine to print and seal folded boxes. Via an interface to the CSDB, serial numbers are automatically assigned to the corresponding production line and are printed on the folded boxes along with the 2D data matrix code. “The device can print on and seal up to 30 folding boxes per minute and can be used on practically all standard folded boxes for medicines and products between 15g and 2kg,” says Dr Caroline Strake, Head of Manufacturing Operations at Arvato. An integrated scale, a camera system and a number of different sensors constantly monitor the quality of the printing and sealing, as well as the weight of each package. “The assessment of the quality and nature (called code grading) of a code is governed by relevant ISO standards and can be guaranteed by means of inspections during the production process and a separate verification device,” explains Jens Wagner, a project manager responsible for the system.
“Serialization in a GMP-licensed production room offers our customers the option to produce their pharmaceutical products quickly and without high investment costs, in line with FMD requirements within the EU, to meet increasing global requirements for serialization and therefore to effectively protect against medicine counterfeiting,” enthuses Axel Mayer, site manager at Harsewinkel, about their new acquisition.
Aggregation: More than just scanning a barcode
The Falsified Medicines Directive will also result in far-reaching changes regarding the logistics involved in distributing prescription drugs and the underlying processes. While the serial numbers will not be verified until the medicines are handed over to patients, the upstream stages in the supply chain must also record the codes to ensure appropriate status management in the national verification systems. Arvato offers its customers a number of logistics concepts that are geared to satisfy the serialization requirements, in some instances even exceeding them. Arvato has an additional machine that generates labels for aggregation on shipment boxes and pallets, which provide information about the entire content of the shipment unit with a single scan. This makes business processes more efficient. Aggregation is already a requirement in many countries outside the EU.
Flexibility through postponement
In addition, through its postponement solutions, Arvato is offering the flexibility required with reduced inventory sizes. Products are stored in a country-neutral condition. Just before shipment, they are provided with country-specific labels and package inserts in specially isolated production areas. These are then serialized in a second step. “Through the combination of serialization and late-state finishing in the warehouse, optimised batches are produced as and when needed. Therefore very expensive medicines are produced immediately only after the receipt of the order. The number of drugs kept in stock for different countries is drastically reduced. The costs for the storage of various packaging materials are also kept to a minimum. At the same time, supply is able to immediately meet demand even in the case of high, irregular fluctuation,” says Dr Caroline Strake. In addition, Arvato handles communication with national authorities concerning some labels. In Italy, for example, the EU Directive doesn’t need to be implemented until 2025, as medicines have already been serialized to a certain extent there by Bollini.
Logistics handling – compliant with all EU requirements
The customer can choose between two concepts for the handling of serialized goods. The light concept is compliant with all current EU requirements at minimal costs, but the serial numbers are not recorded in SAP. In contrast, the Arvato full concept assumes all regulatory requirements for serialization and even exceeds EU requirements. The concept includes multiple checks of serial numbers as well as the continuous updating of their status in the ERP system. Serial numbers are therefore also tracked to the EU hub. “Pharmaceutical companies have greater transparency about where their products are at any time. Customers can also use interfaces to receive reports,” explainslead project manager Jens Wagner. As a value-added service, in the case of discrepancies, a 100 percent check of goods is performed, including the creation of new aggregation. “With our full concept, customers are even more prepared for the future, as it also covers the requirements for handling serialized pharmaceutical products outside of the EU. After all, serialization is not an exclusively European issue but is one that matters worldwide. There are already similar initiatives in place in the USA, Russia and China,” reports Jens Wagner.
Medical Device Regulation (MDR)
A requirement that will become mandatory for pharmaceutical products next year will also be introduced as a general requirement by 2020 for the unique identification of medical devices. This previously voluntary option improves the traceability of medical devices along the entire supply chain. “Encoding leads to greater security in the pick & pack field as well as increased transparency throughout the supply chain,” says Marius Blomeier. As a system, unique device identification (UDI) includes both a machine- readable, unique code on the product as well as an entry in the unique device identification database (UDID). Arvato already manages serial numbers for many of its customers in the medical technology field and postponement concepts are also used to provide things like intelligent kitting or print-on-demand solutions for information accompanying products, such as instructions for use.
To summarise: Arvato’s serialization experts thus cover the entire supply chain in the healthcare segment – from production to logistics handling to the verification system – for both medical devices and pharmaceutical products. “Thanks to our experience with handling serialized products and track & trace in other business units at Arvato, we benefited greatly from the expertise that already exists within Arvato when it came to developing solutions to implement the Falsified Medicines Directive and Medical Device Regulation,” explains Blomeier.