Understanding labelling limitations

Labelling for one region often needs changes to meet requirements elsewhere

With no universal rule of thumb on serialisation and label information, large players in the pharmaceutical industry are discussing ways to rectify the situation. The industry assumption is that the major stakeholders will get together and establish a standard with a third auditing party. As this is not a solution for the immediate future and multinationals distribute pharmaceuticals in multiple countries, it represents a major challenge for packaging and labelling providers. The regulations are broad and drug companies have different ideas about best practices. What works for the labelling on a product headed to Asia may differ significantly from one targeting the North American market.

For now, the options for drug manufacturers boil down to either complying with local information requirements for serialisation on a product by product basis or designing labelling systems that can implement label changes to meet different export requirements (labelling a certain way for one region and changing it to meet requirements somewhere else, for example).

Compounding this issue is the fact that the type of information required on a pharmaceutical label is also getting more expansive. When the US Food and Drug Administration (FDA) put out its new regulation for label requirements, it did so with only the drug prescriber/doctor in mind. The regulatory requirements and information did not include information for the consumer.

Packagers were forced to devise ways to include patient use details on drug labels. Now, there is more of an effort to make the information easier for the patient to understand. The most common way is to use labelling that has data for the consumer on the surface of the product with an additional booklet that incorporates information for the doctor.

Regulatory agencies are also turning their attention to potential migrants or leachables from labels that might seep into the drug. This concern includes containers, labels and the substrate that adheres the label to the container. More sensitive analytical methods enable regulators to detect leachables at lower levels. Despite an increase in leachable oversight, no laws are on the docket. The regulations are written very broadly and put the onus on the drug manufacturer to ensure the suitability of the packaging material and certify that it will not impact the quality or safety of the drug. It is broad enough not to require any new laws or regulations.

No event in North America will offer more pharmaceutical packaging solutions and education than Healthcare Packaging EXPO, colocated with PACK EXPO International 2018 (1417 October, McCormick Place, Chicago, IL, USA). Healthcare Packaging EXPO will provide access to a wide range of pharmaceutical and packaging technologies and insights, as well as offer real-world examples of ways that current pharmaceutical companies deal with labelling.

Produced by PMMI, the Association for Packaging and Processing Technologies, Healthcare Packaging EXPO will host 300 exhibitors in one place from markets ranging from pharmaceuticals, biologics and nutraceuticals to medical devices. In addition to packaging solutions, the event will feature serialisation insights and solutions in track-and-trace, automation and continuous processing, advanced automation, sensor-enhanced packaging, blockchain technology and more.

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