Packaging and label management in pharmaceuticals is crucial for patient safety. Developments in pharmaceuticals and life sciences are taking place at an unprecedented rate. Nearly 50% of the recalls in the pharmaceutical industry result from labeling errors. Even minor packaging errors can lead to thousands of deaths and cost pharma companies millions of dollars every year. 

Over time, as markets have evolved, the pharmaceuticals and life sciences industry has also changed. These changes have accelerated since the onset of the pandemic. Pharmaceutical and Life sciences are tightly regulated, and brands must remain compliant while being competitive. 

Here are some of the notable label requirements for pharma labeling artwork that brands must consider.

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• Consistent quality: Labeling does not only communicate the brand and the product, but it also ensures consumer safety. So, all pharma labels must be regulatory compliant. Modern pharma labels are becoming more inclusive with easily readable text and symbols. The pharma label design should also be compatible with e-commerce platforms. 

• ‍Traceability of products: Labels need to include unique identification markers to prevent counterfeits. They also help establish better control over the supply chain. Brands include bar codes, QR codes, device identification codes, and other unique identifiers. Furthermore, labels must also be compatible with tamper-evident packaging systems.

• Inclusivity, accessibility, and digitization: Labels are replacing hard-to-read instruction leaflets with electronic instructions for use or eIFU. The digital format makes products more accessible with diverse languages and interactive visuals. Packaging prototypes have already shown the advantages of using “smart” labels that can count doses and remind patients to get a refill. Even simple QR codes and NFC tags can help embed digital information in the label.

• Reduced go-to-market times: With the onset of the pandemic, we saw drugs and vaccines being developed at an unprecedented rate. Regulatory bodies will also respond to the changes in the market. Brands must be flexible with their labeling to remain compliant. Brands are under constant pressure to meet ever-changing regulatory requirements while trying to get the product launched as quickly as possible. 

• Increased standardization: The pandemic also accelerated collaboration between global bodies. Even though each region has varying requirements, we may soon see increasing standardization for pharmaceutical and life-sciences products. 

Common pharma label design errors + How to rectify them

To stay label compliant with regulatory requirements, it’s important to understand some of the most common errors in pharma labels. Let’s look at some common labeling errors by pharmaceutical companies, and learn how you can avoid them.

1. Gross errors

Gross errors occur when you fail to update your pharma labels with new or updated regulatory requirements. ‍

Solution

Having an automated compliance solution makes it easy to stay on track with changing guidelines. Users can create custom rulesets and make sure your packaging labels are compliant in one click.‍

2. Copy errors

‍Copy errors could mean spelling errors, missing punctuation, or anything in between. Such errors can be confusing and lead to grave consequences, especially in a highly regulated industry like pharma. ‍

Solution

‍Using spell-check tools and copy-check rulesets allows you to immediately catch such errors and correct them immediately.‍

3. Content errors

‍Content errors occur when there is incorrect usage or misplacement of elements in pharma labels such as symbols, warning statements, and numerals.

Solution

‍Custom rulesets allow you to create flexible solutions for your label designs and ensure label accuracy in an instant. 

4. Human errors

‍Inefficient workflows could mean more human errors in your pharma artwork design. Overworked designers are more likely to make mistakes, and gaps in approval processes could increase the risk of overlooked errors.

Solution

‍Label management software ensures a streamlined process and limits any human errors. Proofing and markup tools ensure no errors are overlooked. 

5. Technical errors

‍Having incorrect/dysfunctional barcodes or braille content on your product labels could mean a heightened risk of repackaging costs and product recalls.

Solution

‍Having a software solution with in-build quality control tools such as a barcode scanner and braille reader can minimize these errors and ensure error-proof label designs.

Importance of accurate labeling for pharma labels

Label accuracy is important across industries, but more so for pharmaceutical products due to the following reasons:

• Non-compliance issues: Failure to comply with FDA regulations for pharmaceutical products could lead to potential recalls.
• Loss of brand image: Your brand reputation takes a hit with product recalls as customers lose trust in your brand and its products.
• Compromise in patient safety: Inaccurate or missed label information increases the risks to patient safety and results in grave consequences.
• Cost of fines, repackaging, and recalls: The fines resulting from FDA non-compliance and later, potential recalls could be huge.
• Loss of staff hours: The time dedicated to resolving labeling errors, including investigating their causes and implementing solutions, could be more effectively utilized elsewhere.

Finding the right solution for pharmaceutical artwork management

Remaining compliant and competitive requires an integrated end-to-end solution.

Here are seven ways in which label and artwork management software help pharmaceutical and life sciences brands. 

1. Get a holistic view of projects

As a manager, you can get a holistic view of the current artwork and label development projects using the dashboard view. Gantt view and List view also allow users to manage tasks and timelines with ease to identify any delays and work smarter. You can see which projects are progressing as expected, which ones are currently experiencing delays, and which ones may experience delays.

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2. Reduce errors with checklists

Managers can assign checklists-oriented tasks to reviewers, designers, and other collaborators. These checklists allow stakeholders to understand what they need to check and make sure all the necessary steps are completed. It prevents overlooked errors, quick and precise feedback, and shorter revision cycles. 

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3. Approve artworks with e-signatures

Authenticity and traceability are crucial in pharmaceutical labeling. With label management software for pharmaceuticals, managers can ask stakeholders and reviewers to provide signatures when they approve artwork or a label, enhancing the efficiency of the workflow management software tool. Furthermore, audit trails add another layer of traceability.

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3. Enable collaborative workflows

Label management platforms allow you to build flexible workflows to meet your project’s unique needs. The software solution provides secure file sharing, comprehensive proofing, and feedback tools to enable a seamless workflow. The tools include a color extractor, font finder, spell checker, PDF comparison tool, barcode scanner, braille reader, and more. Collaborators can also use markup tools to leave visual feedback. 

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4. Easily manage label artwork

Labels often contain information and sharing these files over emails and chats for feedback is not recommended. Label Management Platforms come with integrated secure storage and file sharing with access control. Managers can assign access to designers, reviewers, and vendors as required. Managers can also revoke access when needed. Retrieval of files is also easy with auto tags and metadata management. 

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5. Easily revert to old versions

Designers do not have to store every change in a separate file. Version control allows you to store, track, and access all artwork versions from one location. If a design update does not get approved, you can easily track or revert to the old one with version control. 

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6. Automate regulatory compliance

Keep up with changing regulatory requirements and avoid any label errors whether it is gross errors, copy errors, or technical ones with a flexible compliance solution. Artwork Flow’s ComplyAI also allows you to create custom rulesets allowing you to ensure compliance with multiple regulations with one quick check.

Wrapping up

With an integrated end-to-end cloud-hosted solution, artwork and label development can occur in a unified platform. All collaborators can communicate and share relevant information seamlessly without having to switch over to other websites or platforms. This setup improves productivity and reduces the chances of errors creeping in. 

Book a demo to see how Artwork Flow can help you deliver error-free and compliant labels in no time.

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