European Pharmaceutical Manufacturer editor Reece Armstrong sits down with Neil Gleghorn, CEO of labelling provider Kallik, to discuss compliance challenges for manufacturers and the threat of counterfeit medicines.
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What are the current compliance hurdles facing pharmaceutical manufacturers and packagers?
The major challenge faced by most organisations is the proliferation of isolated stove-pipe systems that artificially limit levels of collaboration and insight that can potentially impact the accuracy of labelling and artwork content. Information sharing, transparency and traceability are often limited by obsolete systems and processes that can have a direct on levels of compliance. There is also a reluctance to change amongst some of the larger manufacturers due to the perceived risk of introducing new technologies, however, without taking this step organisations are at risk of becoming uncompetitive and unable to attract a modern workforce.
What are on the potential implications of Brexit on labelling in pharma?
It is currently acceptable for drugs and devices manufactured outside of the UK and sold into the UK to carry the EU address of the Marketing Authorisation Holder (MAH) to distribute products in the UK, but this may not be the case if a no-deal Brexit is reached. Simply, these products would need to carry a UK address, and post transition could even be required to carry UK and EU MAH addresses. Changes such as these can have a major downstream impact on supply chain operations. Getting all partners adequately prepared for an unknown set of labelling changes is creating major headaches for the healthcare industry right now. Furthermore, as we move beyond the transition period (assuming there is a deal) we’re likely to see more changes to labelling as the EU and UK could go their separate ways when it comes to future legislation.
Does the recent FMD legislation do enough to ensure counterfeit medicines and products won’t reach any stage of the supply chain?
The FMD legislation is a step in the right direction but its success in eliminating counterfeit medicines and products will ultimately come down to the robustness of the solutions put in place by the industry. Given the challenging implementation timescales for FMD, many organisations have implemented stand-alone serialisation and traceability solutions at the point of print and packaging as opposed to upstream labelling and artwork creation to achieve compliance. Where pharmaceutical companies have a limited number of print and supply chain partners it’s feasible to put in place localised processes to maintain serialisation integrity, but this becomes far more difficult for global industries using potentially hundreds of supply chain partners across their print and packaging operations.
A better approach is to manage variable labelling content within the labelling and artwork solution as opposed to down at the factory floor as this removes the risk and overheads associated with managing serialisation data at a local level. It also simplifies the on-boarding of new supply chain partners and provides global oversight of which products were manufactured and shipped from which partner in which territory. The net result being a much more robust solution with increased traceability that also simplifies audit reporting and proof of compliance.
What things do manufacturers overlook when implementing a strategy for labelling compliance?
Often manufacturers overlook the need for simplifying collaboration, providing greater process transparency and ensuring that audit reporting is an embedded part of the solution as opposed to being an add-on. The need for board level sponsorship and buy-in across the key stakeholders tends to be overlooked with individual business functions attempting to install localised solutions that simply fail to connect to one another resulting in poorly designed processes and minimal gains from investment. We believe that labelling is a board level topic and for it to be successful there needs to be enterprise-wide buy in and user adoption. Executive level sponsorship is needed because a proper labelling strategy will drive change and will require the business to grasp the opportunity it presents to rationalise their labelling estate and deliver real downstream productivity gains.
What are some of the upcoming technologies that you think we can expect to see implemented for labelling in pharma?
I’d expect to see an increasing shift towards the adoption of web-based technologies. Cloud-based solutions can simplify the on-boarding of new supply chain partners and production plants and make it easier to scale up and down during periods of growth or contraction without the associate costs of on-premise solutions. Technologies that provide greater levels of autonomy and decision support without risking non-compliance such as Rules Logic Engines and greater use of more modern, intuitive UI technologies are likely to feature more across labelling solutions. The key point here is ensuring that everything becomes connected, eliminating the need to share, review and approve labelling content via uncontrolled email, spreadsheets and documents.
How important is traceability during labelling and what can be done to help manufacturers keep track of their products?
Certainly for the pharmaceutical industry it’s needed to comply with the Falsified Medicines Directive, but the need for traceability is not limited to the supply of medicines. It also equally applies to the supply of medical devices, chemical products and cosmetics and potentially extends into other industries.
We view labelling content as being the master source for product traceability. Traceability also goes much further than the requirements set out in the FMD as it also applies to medical devices, although not to the same level of granularity as serialisation. Legislation and regulation such as the US FDA UDI and the EU MDR require that medical device products can be identified and traced from healthcare providers back to the original manufacturer and by managing variable data such as LOT and Expiry within the labelling and artwork management solution makes it easier to trace products back to source.