Online zero-defect labelling

Labels on pharmaceutical products are the work of many hands. Coordinating the needs of marketing teams, product experts, regulators and end users can be a complex task, with no margin for error. Web-based management of the labelling process is one way to ensure compliance and inspire confidence.

Product labels may not be the foremost consideration in developing a new drug treatment, but they have a major role in regulatory compliance, brand messaging and patient safety. The label may be small, but it must contain important information, such as dosing directions, contraindications and corporate logos.

‘Labelling often gets overlooked because it comes at the end of the production process,’ says Dave Taylor, sales director and products manager for Prisym ID. ‘But people use labels to inform patients, track and trace products, push brand identity
and, increasingly, provide assurance that the product is not counterfeit. If the label isn’t right, then the product isn’t going anywhere.’

USFDA statistics show that labelling non-compliance is one of the top reasons for product recalls, often due to problems that are relatively straightforward to fix.

Zero defects
Prisym ID is a developer of barcode and radio frequency identification (RFID) solutions. Through 20 years of delivering high quality labelling and Auto-ID systems to a range of industries, the company has developed a simple, accessible solution to ensure ‘zero-defect’ labelling.

‘It is a system to guide expert users and non-experts, like the marketing team, through the labelling process to ensure compliance,’ comments Taylor. ‘Part of the purpose of a label is to keep patients safe, so from the recalls you could infer that they are not keeping patients safe enough. Labelling experts understand the important elements, but there are so many boxes to tick and so much information that you need to get all of the right people involved in the process to improve patient safety and avoid damaging your brand.’

Ensuring that all of the right information, security features and branding elements are present on a small label is no simple task. Further, all stakeholders must sign
off the label, and any solution used must be flexible enough to adapt to the changing needs of regulators or marketing teams. For Taylor, the answer lies in web-based
labelling systems.

Accuracy, accountability, accessibility
Prisym ID’s solution has undergone a long process of iterative development. The firm was approached in the 1980s by a large pharma company to develop a technology for controlling all areas of business relevant to injunctions it had from the FDA. The result
was a GMP-based software tool built specifically to oversee compliance in pharma labelling.

‘It has evolved over 20 years and the next stage is web-based,’ explains Taylor. ‘Accessibility of information is key. Many organisations are decentralised and there are many different inputs that come from teams spread around the world. Web-based solutions reach out to hundreds of users across many different regions. You can deploy it pretty much instantly, and it can be rolled out as organisational structure or regulations change. Furthermore, it is cross-platform, so you could approve a label on an iPhone. In fact, we’ve already done that in the lab.’

Greater use of PDAs may well define the future of Prisym ID’s solution, although there are security issues to address. For now, the company has put forward an accessible and customisable solution honed to the specific needs of the pharma industry.

‘We are not saying that the era of client-server technology is over, but the web-based service sits well next to that architecture, and for some small customers there is the
clear cost benefit of having no infrastructure to manage,’ says Taylor.

Web-based labelling solutions are not the future, they are already here, and they are as much for small companies as for pharma giants.