Pharmaceutical packaging needs to adhere to strict regulations. It’s a given. Because even a minor mistake could lead to recalls.

Recently, Sun Pharmaceutical Industries had to recall cartons of drug used to treat low testosterone levels in the US market for incorrect labelling.

As per research, nearly 40% of pharmaceutical product recalls are due to labelling errors. That’s huge! Such incidents could negatively impact a brand and lead to heavy losses.

Hence, validating packaging artwork before it heads out to printing is important.

But if you think of artwork management as a cumbersome process, think again. Every common challenge that you face has a solution that you need to be aware of. The right tools for pharmaceutical artwork management can help you maximize productivity and minimize the drug’s time-to-market.

Let’s have a look.

Top 3 obstacles in pharmaceutical artwork management

Artwork management in pharmaceuticals is viewed as a tough process owing to the changing nature of the market and regulatory requirements. The most common challenge companies face are:

1. Collaboration

When it comes to artwork, collaboration is important irrespective of any industry. You need to employ an efficient platform that assists collaboration. However, most companies are still stuck with outdated methods.

For example, emails. Although emails are convenient and popularly used for communication, they aren’t the best means to keep track of feedback and changes. In fact, if the team uses multiple channels such as phone, chat, this becomes all the more difficult.

2. Regulatory validation‍

Pharmaceutical packaging must comply with a variety of regulatory guidelines, which can vary by country or region. Compliance with Good Manufacturing Practice (GMP) guidelines and local safety measures is crucial. Legal teams must thoroughly proof packaging artwork changes to ensure they meet regulatory standards. Any errors, such as incorrect translation or missing regulatory symbols, can result in fines, product rejections, or warnings from authorities.

For instance, packaging that includes regional scripts, braille, or other language-specific elements requires specialized experts to validate these elements for accuracy and compliance. Failing to meet these regulatory standards can lead to costly fines and potentially harm the brand’s reputation.

3. Resource access

When designing pharmaceutical labelling, you’ll need constant access to multiple files. These could contain information on the chemical composition, the core datasheet, or compliance rules. Easy storage, retrieval, and management of these files often become a challenge if they are stored across multiple locations and as different file formats.

How to maximize productivity in pharmaceutical artwork management

The challenges pharmaceutical companies face when managing artwork relate to managing resources, communication, and collaboration efficiently. Here’s when tools can help. A tool like Artwork Flow provides companies a practical approach to eliminate proofing errors and maximize productivity

An artwork management software helps with:

1. Online proofing tools

Proofing tools play a crucial role in reducing human errors in pharmaceutical packaging. In addition to basic spell-checking, advanced proofing tools offer a range of features designed to enhance accuracy:

• Font finder: Ensures that the correct fonts are used throughout the packaging, particularly important for legibility and brand consistency.
• Color extractor: Verifies the color accuracy of packaging artwork, ensuring that the colors are consistent with brand guidelines and meet regulatory requirements.
• Barcode verification: Ensures that barcodes are correctly formatted and scannable, preventing issues during product distribution and sales.
• Version comparison: Highlights the differences between artwork versions, making it easy to spot any changes and ensure that all updates are compliant.
• Braille reader: Verifies that braille is accurate and properly placed, ensuring accessibility and compliance with regulations for visually impaired users.
• Measurement scale: Ensures that the dimensions of the packaging artwork are accurate and meet the required specifications.

These tools ensure that every element of the packaging is thoroughly checked for accuracy, compliance, and consistency, minimizing the risk of errors that could lead to costly mistakes or regulatory issues.

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2. Version control

While working in a collaborative environment, it is essential to ensure that everybody is looking at the right version at any point in time. Since pharmaceutical packaging artwork approval involves handling several data sets, managing documents in a uniform file-format is essential.

Version control helps keep track of revisions, easily understand changes, and make collaborative editing error-free.

3. Easy data access

Artwork Flow provides a cloud asset library that is a repository of all reusable brand assets like logo, labelling and packaging templates and more. This helps ensure that resources are available to all stakeholders throughout the packaging development and product release.

Important files such as the Company Core Data Sheet (CCDS) - can be managed and accessed from a single point.

4. Automating regulatory compliance

In the pharmaceutical industry, regulatory compliance is paramount. Ensuring that packaging labels meet stringent legal requirements can be a complex and time-consuming task. However, AI-led automated checks can simplify this process by scanning the entire artwork for compliance with industry standards.

Here’s how:

• AI-driven compliance checks: AI algorithms can scan the artwork for mandatory regulatory information like warnings, dosage instructions, ingredients, and safety symbols. The system flags any missing or incorrect information based on predefined compliance rules, such as FDA or EMA guidelines.
• Automated region-specific validation: For international markets, AI can quickly verify that the artwork meets regional regulations, including language translations, braille, and region-specific symbols. This reduces the risk of compliance issues due to oversight in multiple markets.
• Error detection: AI tools can identify common mistakes, such as missing regulatory codes, incorrect font sizes for legal information, or improper placement of critical symbols, and automatically flag them for revision before final approval.

By automating these regulatory compliance checks, pharmaceutical companies can save time, reduce human errors, and ensure that packaging is consistently compliant with global standards.

5. Artwork feedback and approval

Pharmaceutical packaging is dynamic and laws often change across geographies. What works in one country might not work in another. This means that teams in different locations need to make sure the pharmaceutical packaging artwork is compliant. Artwork management software usually provides various tools for easy collaboration. For example, Artwork Flow offers an Annotation feature that allows reviewers to drop pins and comment on artwork files.

6. Custom workflows for task management and review

Managing complex artwork approval processes requires efficient task management. Custom workflows allow teams to set up tailored processes for reviewing and approving packaging artwork, ensuring that no detail is overlooked.

Here’s how custom workflows can streamline your process:

• Task Checklists: Custom workflows enable you to create task-specific checklists that guide the approval process. Whether it’s verifying legal text, checking for missing symbols, or ensuring regional compliance, a comprehensive checklist ensures every item is reviewed. This helps teams follow a standardized process without missing any key steps.

• Approval phases: Custom workflows also allow you to define different approval phases based on the task complexity, such as initial review, regulatory validation, and final sign-off. This ensures that each piece of artwork goes through the necessary stages of scrutiny before it is finalized and sent for production.

• Comprehensive review tracking: Every review task is tracked and documented, providing a clear audit trail for future reference. This is particularly valuable when demonstrating compliance during inspections or audit.

By integrating custom workflows into your artwork management process, pharmaceutical companies can streamline approvals, minimize errors, and improve collaboration across teams.

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Endnote  

Artwork management in the pharmaceutical industry encompasses project management, label regulatory control, watching market trends, and resource management. An efficient pharmaceutical artwork management software can be a reliable option for pharma manufacturers to streamline their packaging processes and keep pace with the changing market dynamics.

What challenges do you face when managing pharmaceutical packaging artwork? Could AI-led compliance tools or custom workflows help your team? If yes, book a demo with our experts today.