Connected labelling: the ultimate in content management complexity?
Agnes Cwienczek shares how we can address the global labeling management burden
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Compared to progress in other areas of regulatory information management, labelling continues to stand apart as a haphazard jumble of systems and processes which lack any real connection or consistency with core systems. The resulting need for manual checks can create risk, delay and cost, especially between territories. AMPLEXOR’s Agnes Cwienczek considers how to transform the situation.
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The global labelling management burden in life sciences is multiplying at a pace. Failure to respond quickly to changing product information or market requirements can result in delays to market, or rejected product registrations, with an impact on sales, revenues and market profile.
Finding a solution sooner rather than later has become a priority, then.
A big part of the problem is the way content interdependencies are managed– ie how a change anywhere along the safety-regulatory-manufacturing-supply chain continuum will affect all label content, from the global ‘core data sheet’, to patient-facing product information in each country.
More often than not, label status tracking still happens in Excel spreadsheets or home-grown systems, with content updated on a country-by-country basis using dedicated labelling tools. These are rarely connected to companies’ registration and submission planning and management tools, preventing a clear line of sight, and management capability, across all labelling activities.
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How to manage volatility?
The main challenge is companies’ inability to efficiently map country/label interdependencies, so that changes can be rolled out promptly and reliably wherever new requirements apply. This is often far from straightforward - Latin American countries, for example, may be dependent on Europe for labelling convention for tablets, but on US product information for medicinal solutions.
Where submissions are bundled and/or split at country level in order to comply with local regulations or company internal needs and strategies, there are further considerations as companies try to maintain traceability – especially as changes trickle down to dependent countries.
In addition, of course, labelling changes can be triggered at different points in the drug ecosystem. While a change to the benefit/risk profile of a drug will drive revised labelling requirements from the global core of the organization, regulatory changes local to a reference country can drive a need for amendments both up and down the chain – up to the core, and down to dependent markets. Therefore, any solution cannot be one-directional in its treatment of cascading changes.
Portals are not a panacea
One approach life sciences companies have taken to manage labelling changes, is to create data-exchange portals between global and local functions – so that the different points in the international labelling management chain can collaborate and report back on requirements and related progress. However, even this relies too heavily on manual updates and process repetition.
In addition, none of this takes into account the fuller safety-regulatory-manufacturing-supply chain continuum. Complete labelling traceability, for compliance, reporting, and safety/risk management, depends on content and processes being open to easy scrutiny right from one end of the chain to the other - from a safety signal, to the regulatory submission and approval, through to product receipt by pharmacies or hospitals.
Data exchange portals often fail to take into account the fuller safety-regulatory-manufacturing-supply chain continuum
True end-to-end label and product tracking and change management ideally needs to encompass artwork updates, and follow-through into and beyond warehouses. While, up to now this broader perspective and ambition remains largely aspirational, achieving complete end-to-end traceability and control is something life sciences organizations are increasingly attuned to in their vision for process improvements.
Certainly, the bolder and more innovative firms become in their quest to expand their markets and portfolios, and the more they become subject to intensifying regulatory/public safety criteria, the more meticulous and efficient they must be in their monitoring and process controls.
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Keeping one eye on the future
To keep pace with regulators’ growing safety controls and electronic data submission requirements, companies must upgrade their approach to labelling management with some urgency now. Many already have 3-5-year change programs underway, with the aim of establishing holistic, transparent and connected global label management environments.
These comprehensive plans are encouraging, paving the way for a definitive source of labelling truth, in the form of central master data - from which everything else flows. They allow for intelligent workflow - as an efficient and reliable means to assess the impact of label changes/calculate interdependencies; to drive through changes with reduced manual intervention; and to facilitate greater collaboration across departmental, country and supply-chain boundaries.
We are paving the way for a definitive source of labelling truth through central master data
Ideally, plans should ideally be cross-functional too. They should allow for connection with global ERP/manufacturing systems; inclusion of local stakeholders in any tools and processes; and future automation – for instance, structured authoring of labels and patient information built from approved master content assets. Investment programs should factor in everything from how country-specific requirements are captured, the knock-on effect of changes across the global organization, and the interplay of different operational functions, to the potential for content re-use, once approved ‘fragments’ or blocks of text/icons/images are filed in the master repository.
It is still early days, but there is much to gain by being thorough.
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