How the pharma industry is keeping up with changing labelling regulations and compliance
Graham Francis, product marketing manager at Kallik writes about how new technologies are helping pharma companies keep up with changing labelling regulations.
‘Labelling’ is a broad term that covers a number of elements, such as control and package labels, directions for use, and maintenance manuals. It’s also not limited to print and encompasses electronic media presented via a mix of user devices.
With the evolving pharmaceutical market, the industry has had to shift and adapt to the changing times. There’s a need, now more than ever, to balance complex regulations, rising consumer demand and shifting market realities. And due to the uncertainty surrounding Brexit, potential changes in regulations will increase organisations need to stay agile to achieve compliance.
Regulation is of paramount importance and a challenge to manufacturers every day. Therefore, processes need to be adapted to meet changing production demands of speed, safety and flexibility while still continuing to comply with regulations. So, how can the industry overcome some of the biggest challenges it faces, embracing new technologies in order to empower workforces and allow the industry to move forward?
Relationships
In line with this, the relationship between document-centric regulatory environments, content centric labelling and artwork processes will be of paramount importance. Small but problematic details can lead to significant inaccuracies in both packaging and labelling. This therefore requires content alignment, where approval and review processes need to be visible and auditable to check accuracy of spelling, artwork, graphics, regulatory content and barcodes at every stage of production. In building more collaborative processes, labelling executives should seek to:
- Bring all assets under control in one place where they can be reviewed, approved and version controlled
- Surface and share regulatory and product information buried within documents and spreadsheets to better substantiate claims
- Store all labelling content, translations and artwork as digital re-usable assets, whether printed or published electronically
- Take steps to simplify collaboration across all areas of content collation, artwork authoring review and approval
Remaining flexible and agile
Maintaining compliance will comprise of a connected and agile process between print and electronic labelling. Fundamental to success here is getting labelling compliance right for printed labels first as opposed to implementing new technology to deliver eLabelling. Many organisations often start out thinking they need to find new ways to present content electronically, but quickly go on to discover that the problem they really have is around levels of consistency across printed labelling content. Once this challenge is addressed, re-purposing structured approved content to be able to present this electronically becomes much simpler.
To bridge the gap between consumer packaging groups and converters, the pharma industry will require an evolution of traditional manufacturing infrastructures. The obvious and ultimate solution is electronic packaging and smart labels to enhance the consumer experience and strengthen brand loyalty. New smart devices will inevitably become the new normal and manufacturers will then search for new functionalities to continuously achieve the best possible packaging and labelling.
Simplify content collation
Making it easier to capture multilingual labelling and embracing linguistic minorities will better position manufacturers to exploit growth in emerging markets. Tailoring content collation to meet localised regulatory and product labelling requirements through expanded use of business logic will lead to less errors and lower the risk of non-compliance. Graham Francis, product marketing manager, Kallik, sees labelling and supply chain executives achieving measurable benefits delivered by embedding business logic into labelling content collation processes as they begin to eliminate reliance on tribal knowledge. “They will also be better positioned to satisfy market-specific labelling variants and quickly adapt to ever-changing market and regulatory needs. Organisational decision making will also improve.”
It goes without saying, that all internal and external stakeholders need to be connected to eliminate dependency on uncontrolled processes (e.g. email) this makes it easier for labelling execs to capture and report on performance against key KPIs and to target and implement process improvements that will have a measurable impact on performance.
Digital labelling
Digital labels can also help solve the issue of adapting and are quicker and easier to update compared to print, as well as making it easier to present content in a coherent and attractive format. This will aid patient transparency and see manufacturers more easily adapting to localised language needs leading to better informed patients and improved outcomes. Graham adds: “Organisations must also move from processes that re impossible to measure to ones that are fully transparent as part of the migration towards digital labelling,” adds Francis. “This will sharpen focus on inefficiencies in areas of the business that are true bottlenecks, rather than risk assigning valuable resources to projects that might have limited impact on productivity.”
Smart packaging
Smart packaging will empower manufacturers to rapidly make changes to label content without enduring the costs associated with reprinting and repackaging. Smart packaging will enable manufactures to be more responsive and adaptable, without facing the normal constraints imposed by physical printed labels. With this more dynamic approach, patients could have instant access to all information in the language of their choice and as we move closer to patient-centric treatments we could envisage tailored personalised labelling becoming more prevalent.
Logistics and distribution
The move towards a more agile, connected community through embracing digital supply chain concepts is never going to be an easy transition, but the benefits are clear to see.
Despite all the challenges of migrating from a vertical to a horizontally integrated business, increased use of manufacturing and distribution partners spanning a global market means that industry has to change if it is to remain competitive.
But it’s not just external partners that need better integration, each internal function right from R&D to customer fulfilment needs an end to end transparency to support real-time collaboration and informed decision making. The only way to do this is to have all stakeholders fully connected and empowered at all times.