Serialisation, verification and traceability in automated secondary packaging

The requirements for the traceability of medicinal products have increased significantly in recent years. The European Union’s Falsified Medicines Directive (FMD) and, in particular, Delegated Regulation (EU) 2016/161 set out requirements for the unique identifier, the anti-tampering device and verification via the European data storage and retrieval system for the medicinal products for human use concerned.

Serialisation is no longer solely an IT task. It must be integrated into secondary packaging processes and interact reliably with printing systems, camera technology, line control and higher-level data systems.

This raises a key question for marketing authorisation holders and contract manufacturing clients: how can regulatory requirements, reliable data processing and efficient packaging processes be combined?

Serialisation as an integral part of secondary packaging

This includes, in particular, the 2D Data Matrix code, in which the unique identifier for medicinal products subject to FMD is encoded. This comprises the product code and unique serial number, as well as the batch designation, expiry date and – where required in the relevant Member State – a national reimbursement or identification number. Depending on the packaging, solutions such as adhesive seals, security perforations or similar measures are used.

This makes labelling and tamper-evidence features integral parts of the packaging process.

In-line inspection: Combining labelling and quality control

A key challenge lies in reliably inspecting the labelling directly during the ongoing packaging process.

Once the code has been applied, it is inspected by camera systems. Among other things, these systems can check the legibility, print quality and the conformity of the labelling with the stored data.

Defective or illegible packages can be automatically diverted from the process. The key here is the interplay between printing technology, image processing, line control and the relevant data structures.

At Complex Pharmaceuticals, integrated printing and camera systems are used for this purpose. The inspection takes place directly within the packaging process and supports end-to-end quality control, without treating serialisation and labelling as a downstream process step.

Data integrity throughout the entire process chain

The processing of serialisation data does not end at the packaging line. The serialisation data generated must be processed reliably in accordance with the agreed responsibilities and transferred to the client’s designated systems or, via the interfaces provided for this purpose, to the relevant serialisation systems.

For medicinal products subject to FMD, connection to the European Medicines Verification System is also relevant. The data required for placing the products on the market is entered into the European Medicines Verification System (EMVS) in accordance with the defined responsibilities. In Austria, verification takes place via the national medicines verification system, AMVS.

The systems along the process chain can be broadly divided into different levels as follows:

• Level 1 – Sensors and actuators: Printers, cameras and ejection devices directly on the packaging line.

• Level 2 – Line control: Control and management of print jobs, inspection results and process signals.

• Level 3 – Site management: Management of serial numbers, orders and relevant process data at site level.

• Level 4 – Enterprise / Cloud: Integration with the customer’s higher-level systems or external serialisation networks.

The GxP-relevant computerised systems and interfaces used for this purpose must be monitored in accordance with their intended use and – where relevant to GMP – operated in a qualified or validated manner. Equally important are their integrity, traceability and clear association with the respective process steps.

At Complex Pharmaceuticals, serialisation processes are therefore regarded as an integral part of the overall packaging and documentation structure. Standardised interfaces facilitate integration with contract clients’ systems and the structured transfer of relevant data.

Conclusion

Serialisation is an essential regulatory component of modern pharmaceutical packaging processes for the medicines concerned. In addition to the serialisation required by regulation, aggregation can be used to link individual serialised packs to higher-level packaging and logistics units. Unlike serialisation, aggregation within the framework of the EU FMD is not, in principle, a mandatory requirement of Delegated Regulation (EU) 2016/161, but rather an additional technical and logistical function.

It is only through the interplay of labelling, camera inspection, line control and data processing that a traceable process structure is created across the various packaging levels.

For contract manufacturing clients, this means that high-performance secondary packaging today must do more than simply operate flexibly and efficiently. It must also be capable of reliably integrating regulatory requirements with digital data processes.

Our experts will be happy to advise you on integrating your production lines and data structures with our systems. Enquire about a partnership now.