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Graham Francis – product marketing manager Kallik
LOGISTICS & DISTRIBUTION
Balancing act How the pharma industry is keeping up with changing labelling regulations and compliance ‘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