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3 min read
When discussing pharma packaging artwork, the common perception across the industry is that it falls under Regulatory Affairs. After all, artwork ensures label compliance — the right information, the right format, for the right market.
But is that the full picture?
From years of experience in artwork management, we have observed that artwork operations are much more cross-functional than most organizations realize. While ownership often lies with Regulatory Affairs or Supply Chain, and occasionally Packaging, in reality, it is a shared responsibility — a collaborative ecosystem that connects compliance, manufacturing, supply, and quality together.
Why the Debate Exists
Every pharmaceutical company structures artwork ownership differently.
Some align it under Regulatory, emphasizing compliance and labeling accuracy.
Others position it within Supply Chain, focusing on agility and production readiness.
In certain cases, Packaging leads the process due to its technical control over dielines and component specifications.
This variation across the industry inspired this discussion — because while the ownership may differ, the objective remains constant: to deliver compliant, accurate, and timely artworks that ensure product availability and patient safety.
The Core Purpose of Artwork Management
At its core, pharma artwork management serves multiple dimensions:
- Compliance – ensuring regulatory accuracy and adherence to local market labeling norms.
- Branding – maintaining visual identity and consistency across markets.
- Operational Efficiency – driving Right First Time (RFT) metrics, turnaround time (TAT) improvements, centralization, technology adoption, and continuous process enhancement.
Artwork isn’t merely about design — it’s about ensuring regulatory-approved information is accurately reflected on print-ready packs that move seamlessly through manufacturing and distribution.
Who Drives the Process?
In most organizations, Regulatory Affairs initiates the majority of artwork changes — especially for:
- Submission Artworks (for dossier submissions to health authorities)
- Market Launch Artworks (for new product introductions)
- Post-Launch Updates (for label or content revisions)
The Regulatory team is familiar with market-specific requirements, submission timelines, and updates. Naturally, they are the first to identify when a change must occur and initiate the corresponding artwork change control.
However, technical changes — such as component modifications or dieline updates — typically originate from the packaging site.
Beyond Regulatory: The Cross-Functional Network
Once initiated, artwork creation becomes a multi-stakeholder process:
- Packaging Teams provide dielines and specifications that define the physical structure of the artwork.
- Artwork Studios converts regulatory text and technical specs into final design files.
- Proofreaders and Quality ensure textual, graphical, and barcode accuracy through manual and electronic checks.
- Supply Chain verifies component numbers, serialization details, and SAP data alignment before release.
Each team plays a critical role in ensuring the artwork is correct the first time and reaches production without delay.
The Case for a Central Artwork CoE
One change to advocate across the industry is the creation of a Central Artwork Center of Excellence (CoE).
An independent CoE can:
- Eliminate ownership confusion between Regulatory and Supply Chain.
- Standardized processes and RFT metrics.
- Leverage technology platforms for automation and proofing.
- Foster end-to-end visibility across all functions.
While many organizations continue to position artwork under Regulatory or Supply Chain, a centralized model ensures accountability, agility, and collaboration.
Key Takeaways & Industry Best Practices
1. Treat Artwork as a Cross-Functional Asset
Recognize that artwork execution impacts multiple domains — from regulatory submissions to supply continuity. Cross-functional collaboration is crucial for avoiding compliance delays and stockouts.
2. Establish a Clear Governance Model
Define roles, responsibilities, and escalation paths across Regulatory, Supply Chain and Packaging. Avoid overlapping ownership or unclear approval hierarchies.
3. Create a Central Artwork Center of Excellence (CoE)
A dedicated CoE brings standardization, visibility, and technology integration. It ensures RFT improvement, process efficiency and unified reporting.
4. Invest in Technology & Automation
Adopt tools for digital proofing, version control, and workflow management. Automated proofreading and barcode validation systems reduce manual errors and enhance compliance speed.
5. Measure What Matters — RFT, TAT, and Compliance
Track Right First Time (RFT) at every stage — from input accuracy to approval turnaround. Regularly review metrics and drive continuous improvement.
6. Build Strong Supplier & Partner Alignment
Include external partners — such as art studios and printing vendors — as part of the quality and compliance ecosystem.
Final Thought — It’s a Collaborative Ecosystem
Pharma packaging artwork may start with Regulatory Affairs, but it succeeds through collaboration.
Each stakeholder — Regulatory, Packaging, Supply Chain, Manufacturing, and Quality — brings a critical piece of the puzzle.
The true strength of artwork management lies in recognizing it as a collaborative ecosystem, not a siloed function.
Because ultimately, accurate artwork isn’t just about compliance —
it’s about ensuring patients receive safe, correctly labeled medicines on time.
