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Late-stage customisation in pharmaceutical manufacturing includes, for example, adding variable data to labels or packaging that are pre-printed. This allows the manufacturer to customise product labelling for certain markets, customers, or products without having to stock individual packaging materials for each possible variant. Additionally, the flexible production of smaller batch sizes creates new requirements for automatic and fast changeovers. How can pharma manufacturers implement a tamper-evident, flexible solution for low and medium volume production?
Choosing Late- Stage Customisation
Government organisations around the world have initiated or already implemented laws and regulations that aim to ensure patient and consumer safety by preventing falsified and counterfeit medicines from illegally entering the supply chain. The EMA defines falsified medicines as those which may come in fake packaging or contain the wrong ingredients or low levels of the active ingredients (1). Counterfeit medicines are those that infringe trademark law or do not comply with intellectual property rights. Falsified and counterfeit medicines can pose serious risks to patients and consumers. For example, in the EU, pharmaceuticals need to be labelled and packaged specifically for each member state in which they are marketed, according to each country’s individual requirements. Counterfeiting can be reduced significantly by implementing product serialisation, which requires a system to track and trace medicines throughout the entire supply chain. Serialisation of prescription medicines will become mandatory in the EU on 9 February 2019. Similar regulations are already in place in other regions.
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