GMP compliant pharmaceutical packaging design: 3 tips

When the EU Directive on Falsified Medicines came into force at the end of 2015, the EU gave pharmaceutical manufacturers three years to implement a new range of features to make their packaging GMP compliant. In the light of these increasingly stringent safety demands, we’ve put together a shortlist of three useful suggestions for pharmaceutical packaging designers (and manufacturers).

Tamper-proof pharmaceutical packaging design

GMP compliant pharmaceutical packaging should be easy for all stakeholders to recognize and understand, while difficult to reproduce at the same time. A proper design should also immediately reveal whether the packaging has been opened or tampered with. This level of safety can only be reached when a packaging has three layers of protection:

1.     Overt anti-counterfeiting measures

Overt safety measures such as

• watermarks,
• embedded filmic security threads,
• holograms
• destructible films and other void materials that leave a ‘VOID’ symbol when a label is removed,
• …

enable stakeholders to identify the brand without requiring special authentication tools. Clearly visible even to the untrained eye, they offer basic protection against falsification.

2.     Covert security features

Covert security technology is harder to copy than overt measures and is invisible to the naked eye. Depending on the type of technology used, covert security features require specific tools such as a magnifying glass, a UV light, a reactant pen, … in order to be detected. Examples of covert security features are:

• embedded UV luminescent fibers,
• UV prints with custom designs and colors,
• randomly applied infrared taggants (chemical markers),
• inorganic taggants added to plastics, coatings, inks, adhesives, …,
• …

3.     Forensic security features

Forensic security features are invisible as well, but they are embedded in the product instead of the packaging. They can only be detected through laboratory analysis and are impossible to counterfeit. Forensic security features include patented DNA taggants, strings derived from large botanical DNA through segmenting, shuffling and reassembly.

Did you know?

Esko’s WebCenter is a dedicated management system for Good Manufacturing Practices (GMP) compliant pharmaceutical packaging and labeling. It enables you to optimize your processes across all stakeholders, ensuring that your packaging adheres to all the guidelines of current GMPs.   Inspired by Labels and Labeling