Pharmaceutical Labeling: Safety for Medicine

In pharmaceutical production, any deviations in quality have direct effects on the health of people or animals. That is why we place a massive emphasis on maximum reliability in printing, coding and labeling, up to and including the controlled rejection of products or labels. HERMA provides a powerful overall package with that in mind, including standard control systems, serialization, tamper-evident labeling solutions and machine designs in accordance with GMP guidelines with comprehensive qualification.

Medication is as lucrative a field of business as ever for counterfeiters. The EU Commission has responded to this threat with the Falsified Medicines Directive 2011/62/EU that came into force on February 9, 2019, and has provided pharmaceuticals companies with strict requirements for identifying and tracing pharmaceuticals and protecting them from manipulation. We have developed some hugely effective solutions for serialization, track and trace, aggregation and tamper-evident labeling.

Serialization

To comply with the Falsified Medicines Directive, all packaging for prescription medication brought to market within the EU must have a unique, individual serial number. The numbers are generated by official organizations, regulated and stored in a database. Similar solutions are being considered or have already been implemented in many other markets.

• Special precautions are required to record the serial numbers or 2D code of rejected labels or packaging. Such labels or packaging must not be made available or should be made available only with checks.
• HERMA labeling machines can be fully equipped to perform serialization tasks in medicine labeling in compliance with EU regulations or other international provisions.
• Aggregation (that is, the aggregation of serialized products) is often necessary or useful in combination with serialization. The HERMA product portfolio includes the perfect printing and applicator systems for this task.

   

Track & Trace

Where does the product come from? Who produced it? In many markets, the path taken by a drug must be fully traceable at all times – from the manufacturer to the end consumer. Track and trace lets you record its full route along the supply chain in real time. One prerequisite for doing so is that the product can be clearly identified by a serial number. HERMA provides you with powerful printing and labeling solutions for the special requirements involved in track and trace.

Aggregation

Aggregation is the secure combination of individually serialized packages into larger logistical units such as bundles, cardboard boxes or pallets. Unlike the serialization of individual packages, aggregation is not a legal requirement in the EU, although it is in other markets. However, it offers pharmaceutical companies another added benefit: establishing a relationship between the individual products and the logistical units makes it much easier to trace the path of individual medications. That also makes it easier to coordinate recalls or report stolen products, for instance.

• To print the aggregated “group codes” on labels and apply them, HERMA offers particularly reliable print and apply systems for every aggregation level.

   

Tamper-Evident

The EU and many other markets stipulate that pharmaceutical packaging for medicines such as prescription drugs, for instance, requires a tamper-evident seal as a security feature. If you wish to continue using your current folding boxes, the use of tamper-evident labels is a particularly interesting option.

• HERMA offers a range of efficient and reliable solutions for sealing packaging with seals or tamper-evident labels. Our specially developed tamper-evident labeling machines are already deployed in a large number of markets.
• Where transparent tamper-evident labels are used, the adhesive with luminescent particles can be adjusted to enable a UV sensor on the labeling machine to detect the difference between the folding box and label. This allows you to check the successful application of the tamper-evident labels directly.
• If the tamper-evident labeling is printed on, a camera system or contrast scanner can perform this control function.
• If none of these methods work, gloss sensors can be used to detect any difference between the gloss on the folding box and the gloss on the tamper-evident labeling labels, and therefore determine the presence of the labels.

GMP Standards

Quality assurance plays a central role in the manufacture of medication, with direct effects on patient safety. A quality management system in accordance with GMP (“Good Manufacturing Practice”) helps to ensure product quality and the obligatory fulfillment of healthcare authority requirements.

• HERMA pharmaceutical labeling machines are developed and built in accordance with GMP requirements. This is how they help to achieve the prescribed quality levels in the production processes and environment.
• The provisions can vary from country to country.
• GAMP (“Good Automated Manufacturing Practice”) is another closely associated standard. It includes guidelines (which are not legally binding) for codes and programming machine controls. Its aim is to rule out undesirable functions from the outset.