Labeling: Keeping Up with Compliance

November 14, 2018

There’s a need, now more than ever, to balance complex regulations, rising consumer demand and shifting market realities, writes Graham Francis.

Labeling 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 organizations 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?

In line with this, the relationship between document-centric regulatory environments, content centric labeling and artwork processes will be of paramount importance. Small but problematic details can lead to significant inaccuracies in both packaging and labeling. 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, labeling 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 labeling 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 labeling. Fundamental to success here is getting labeling compliance right for printed labels first as opposed to implementing new technology to deliver eLabeling. Many organizations 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 labeling 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 search for new functionalities to continuously achieve the best possible packaging and labeling. 

Simplify content collation

Making it easier to capture multilingual labeling and embracing linguistic minorities will better position manufacturers to exploit growth in emerging markets. Tailoring content collation to meet localized regulatory and product labeling requirements through expanded use of business logic will lead to less errors and lower the risk of non-compliance. Labeling and supply chain executives achieving measurable benefits delivered by embedding business logic into labeling content collation processes as they begin to eliminate reliance on tribal knowledge. They will also be better positioned to satisfy market-specific labeling variants and quickly adapt to ever-changing market and regulatory needs. Organizational 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 labeling 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 labeling

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 localized language needs leading to better informed patients and improved outcomes. Organizations must also move from processes that re impossible to measure to ones that are fully transparent as part of the migration towards digital labeling. 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. It 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 personalized labeling becoming more prevalent. 

Graham Francis is product marketing manager at Kallik Ltd.