Overview

Developing packaging artwork for any product is a complex and time-consuming process, but for the pharmaceutical industry, it is even more challenging. Pharma companies must navigate a maze of strict regulations to ensure patient safety while delivering products to market quickly. Even a minor labeling error can lead to costly recalls, damaged brand reputation, and patient harm.

Automating the artwork management process is a game-changer for pharmaceutical companies looking to streamline workflows, minimize errors, and stay compliant. By implementing a robust artwork management system, teams can overcome common pain points and optimize every stage of the packaging lifecycle.

3 Common roadblocks

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1. Managing submission and commercial workflows:

This is often chaotic and time-consuming. Disorganization and inefficiencies can lead to missed deadlines, increased costs, and heightened compliance risks. Failing to adhere to regulatory standards or timelines can delay product launches, result in costly recalls, and damage brand reputation.

• Chaotic processes and poor communication: Without a centralized system, tracking artwork status, managing version control, and ensuring traceability are challenging.
• Manual workflows: These introduce the risk of human error and complicate record-keeping.
• Strict timelines: Delays in artwork approval impact time-to-market, putting pressure on teams to rush critical stages, often resulting in avoidable errors.
• Regulatory compliance: Meeting stringent guidelines from bodies like the FDA and EMA is complex and requires rigorous checks and approvals.
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2. Inability to track all regulatory changes

Integrating regulatory and quality management systems is crucial for effective data sharing. When artworks are impacted by regulatory changes, they must be accurately tracked and routed to the appropriate departments for design and approval, often with specific Change Control numbers. Without seamless integration, the process can become cumbersome, leading to delays, errors, and non-compliance. This disorganization disrupts workflows, causes communication breakdowns, and jeopardizes product launches and patient safety.
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3. Adhering to regulatory dates:

In the pharmaceutical industry, adhering to regulatory deadlines is crucial, with changes required within 3 to 6 months. Key dates like the 'Regulatory Required date,' 'Effective date,' and 'First Production date' must be meticulously tracked to ensure compliance and avoid costly delays. Managing these deadlines without an efficient system is cumbersome and can lead to missed deadlines, regulatory non-compliance, and potential recalls, complicating coordination and timely implementation.

Overcoming Artwork Management Challenges

Now that we understand the challenges inherent in pharmaceutical artwork management, including version control issues and compliance roadblocks, it becomes evident that leveraging appropriate tools can significantly enhance companies' ability to scale their artwork management processes effectively.

ManageArtworks aids pharma companies in

• Ensuring Traceability and Version Control

Maintaining accurate records of packaging artwork versions is crucial for demonstrating compliance and preventing mix-ups. ManageArtworks' version control features enable teams to quickly identify the correct, approved version of artwork and prevent the use of outdated or incorrect information on packaging. It also streamlines all submission and commercial artwork workflows, ensuring seamless coordination and efficiency throughout the entire lifecycle of your artwork. From initial design and regulatory approvals to commercial deployment and eventual obsolescence, the system provides a centralized hub for managing all aspects of your artwork.

• Maintaining Regulatory Compliance

Adhering to FDA, EMA, and other regional guidelines is essential for pharma packaging. ManageArtworks streamlines the artwork approval process, ensuring all content is reviewed and signed off by the appropriate regulatory teams before release. It also seamlessly integrated with regulatory and quality management systems to share data. Artworks which are affected by a regulatory change with their corresponding Change Control numbers are automatically routed within ManageArtworks to respective departments for design and artwork approval. Additionally, you can import Item codes, FG codes, and component codes available in the ERP directly into the ManageArtworks system.

• Accelerating Time-to-Market

Slow, manual artwork management processes can significantly delay product launches. By automating tasks like proofreading, color matching, and barcode and pharma code validation, ManageArtworks helps pharma companies reduce turnaround times and get products to patients faster.
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Conclusion

In the highly regulated pharmaceutical packaging market, the ability to quickly create compliant, and error-free artwork is paramount. By automating key processes and leveraging a powerful artwork management platform, pharma companies can navigate the regulatory landscape with confidence and deliver life-saving products to patients worldwide.

Explore the solution today!