Counterfeit drugs and their fatal outcomes are in the news nearly every week. The trade with counterfeit medicine like potency pills or heparin is still booming and has a higher margin than the trade with cocaine. For consumers it is nearly impossible to detect whether a product is genuine or counterfeit. Numerous laws and guidelines have already or will come into force all over the world in the coming years to protect consumers from these threats.
Accordingly, Pharmaceutical manufacturers and contract packers are facing the challenge of selecting and implementing appropriate technologies, and connecting them with their production and packaging processes. The safest option undoubtedly consists in a scalable machine and software concept.
On November 27, 2013, the Drug Quality and Security Act (DQSA) was adopted in the U.S. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines the steps required to implement a system that identifies and tracks drugs distributed in the United States. In early 2015, the implementation began on batch level. Since 2017, serialization of primary packaging is mandatory. Though DSCSA law remains unchanged, penalties have been delayed until November 2018 to give pharmaceutical companies more time for implementation.
The biggest challenge for all parties involved, however, will follow in 2019, when the serial number of each individual pack and outer packaging must be known to pharma wholesalers – either in form of the National Drug Code (NDC) or the Global Trade Identification Number (GTIN). First, all drug producers must comply with this law. In an interval of one year each, repackers, wholesalers and dispensers will follow. Exactly ten years after commencement of DQSA, that is end of November 2023, the complete connection and aggregation is supposed to be implemented.
Anti-counterfeiting movements around the world
The European Union‘s Falsified Medicines Directive 2011/62/EU, which came into effect in February 2016, stipulates the usage of coded packaging with unique serial numbers for all prescription drugs starting February 9, 2019. Like in many other countries, the serialization feature is a 2D data matrix code. It contains a randomized serial number, the batch number and expiry date, as well as further data, if required. At the same time, the EU demands a second level of security in form of tamper-evident closures, such as integrity seals or glue, which are recorded in the CEN norm DIN EN 16679:2015-03. They clearly indicate whether a package has been previously opened or tampered with.
In parallel, many other countries are developing and implementing new serialization laws. In the MENA region (Middle East and Northern Africa), efforts for drug traceability are already underway. Saudi Arabia, for instance, initiated the first phase in March 2015 with obligatory data matrix codes on pharmaceutical packaging. Phase 2 - actual serialization - has come into force in 2017. While phase 1 only requires a machine to print data matrix codes, phase 2 necessitates producers and packers to have machines for serialization as well as an IT infrastructure to generate the serial numbers. In Eastern Europe and Eurasia, regulations and laws will also be introduced within the next few years, for instance in Russia. The movement for securing drugs and saving lives is advancing at a rapid pace around the world.
Fulfilling different national guidelines
What are the fundamental differences between the different national or regional implementation stages? The EU, for instance, attributes special importance to tamper-evidence, while the U.S. is implementing the first aggregation step at a very early point in time, thus changing the requirements for both local pharma companies and importers. Despite all differences, all serialization efforts have one thing in common: they might be seen as regional responsibility, but they all have a global impact. Many large drug manufacturing companies operate facilities in different countries and export their products all around the world. Hence it would be very short-sighted to equip packaging lines according to one standard only.
For instance, if a large generic producer from the MENA region not only sells its products in the local market, but also in Europe and the U.S., it will require all pharmaceutical packaging to conform to different national serialization standards, despite the fact that most of them are packaged regionally. The same accounts for contract packers, who must comply with the requirements of their clients, as well as with the laws of these clients’ respective markets. Accordingly, flexible solutions which are able to fulfill far more than just one national guideline are highly sought-after.
Answering global requirements
Against this background, most manufacturing and packaging companies will need to develop and apply a global strategy for the consistent generation and assignment of serial numbers. This calls for solutions that are compatible with in-house processes. Furthermore, new processes must be established for both management and storage of serial numbers. In a nutshell, a serialization and aggregation solution that fits all needs must be highly flexible and modular. It should not only be able to mass-serialize the packed product, verify the codes and apply labels or tamper-evident seals to the packaging. The entire process must also be controlled, and the data must be retrievable at any time. Only this way will producers and dispensing points gain an exact overview of all process steps.
To this end, Bosch Packaging Technology has developed the CPI software for Track & Trace, which can be easily integrated into existing IT infrastructures. The company can rely on its experience from the automotive sector, where automation and connectivity of machines, processes and IT have been tried and tested for years. Bosch has transferred the logic and functionalities to pharmaceutical packaging lines and adapted them to the global Track & Trace requirements.L
Levels for holistic serialization and aggregation
A holistic serialization and aggregation process starts on the application level (level 1). Here, the modular CPS system from Bosch serializes up to 400 folded cartons per minute. The camera system automatically verifies the printed tracking data. Subsequently, a security seal is applied by the Tamper Evident labeler. However, serialization is not limited to folded cartons. Bosch also offers a solution that is able to print and verify labels on bottles. Moreover, a so-called helper code can be applied to the bottom or cap of a bottle, if required. The modules are operated via a central user interface, and the data can be documented (level 2). Apart from the CPS serialization modules, which serialize the smallest sealable unit (i.e. cartons or bottles), Bosch has developed CPA modules for the aggregation of products at different packaging levels, such as bundles, cases or pallets.
To control both operating condition and data at any time, the connection between the physical machine level and the control software must be integrated across many stages of the company IT (level 3). From this level onwards, the CPI solution for Track & Trace can be used. The data connection between all lines makes it possible to monitor them all from one central spot, even if the lines are situated at different locations. All relevant data is available in the entire company network, and all results are recorded in the audit trail. The data sets are bundled with the production results according to aggregation specifications, and sent back to the CPI software. From here, they can be transferred to producer-owned databases.
It’s worth looking at the bigger picture!
Depending on country and guideline, the serial numbers are either allocated centrally or generated by the company. Contract manufacturers in turn receive the numbers from their clients. The CPI solution from Bosch is equipped for all cases. Companies can not only manage serialization from the allocation of the serial number through to the last aggregation step. They can also flexibly connect single components, third party machines, packaging lines, own or third party IT systems and entire factories with each other according to the respective guidelines. Hence it really is worth while looking at the bigger picture – for manufacturers and contract packers, as well as for mechanical engineering companies with a focus on international customers.
On behalf of pharmaceutical industry
Bosch Packaging Technology – product division Pharma is one of the leading providers of process technology and packaging solutions for the pharmaceutical industry. The portfolio includes single units, complete lines and integrated systems for the manufacturing and processing of liquid and solid pharmaceuticals. It also includes process technology, primary packaging, inspection technology for different application fields and packaging types. Secondary packaging with qualification and validation, software solutions for track and trace and technical customer service are also available.
The following product brands are part of the Bosch portfolio for the pharmaceutical industry: Hüttlin, Klenzaids, Moeller&Devicon, Pharmatec, SBM Schoeller-Bleckmann Medizintechnik, Sigpack and Valicare.