Artwork Approval Process in Pharma - 5 Best Practices [2025]
Jun 3, 2025
Did you know that since 2012, the FDA has issued over 15,700 drug recalls in the U.S., with labeling and packaging errors being a frequent cause?
However, for many pharmaceutical companies, the artwork approval process is still slow, manual, and prone to versioning errors.
In this text, we’ll break down what the artwork approval process in pharma involves, why it matters, and how best practices can make it more efficient and reliable.
Let’s begin!
What is the Artwork Approval Process in Pharma
The artwork approval process in pharma refers to the structured workflow used to create, review, and approve product packaging and labeling.
This includes everything from cartons and labels to leaflets and blister packs.
The process goes beyond design, so each artwork file must meet strict safety, legal, and regulatory standards before it reaches production.
What Does the Artwork Approval Process in Pharma Cover
The process involves several key steps to ensure that every piece of packaging meets regulatory, branding, and quality standards before printing.
Those are:
Design creation and formatting.
Review for accuracy and regulatory alignment.
Internal and external stakeholder approvals.
Final sign-off before print or production.
➤ Why it’s Critical:
A single labeling error can lead to misdosing, regulatory violations, or nationwide recalls, which makes the process a key quality control gate in pharma.
➤ Who’s Involved:
Regulatory Affairs: Checks for legal and market-specific compliance.
Quality Assurance: Reviews for consistency and standards.
Marketing: Ensures branding and messaging are correct.
Manufacturing: Verifies technical print and packaging requirements.
More on this later in the article.
➤ Governed by SOPs:
Most pharma companies define this process in internal Standard Operating Procedures (SOPs).
These outline step-by-step how artwork is developed, reviewed, revised, and archived.
➤ Outcome:
An “approved” artwork file ready for production, compliant, traceable, and error-free.
Pro Tip
Signify’s Artwork Validation instantly checks product labels and packaging against current regulations, helping you catch errors before they escalate.
Use it early in your product development process to minimize costly redesigns and ensure every label is market-ready from day one.
What is the Checklist for Artwork Approval Process in Pharma?
Reviewers use an artwork approval checklist to verify critical elements before sign-off.
Thoroughly using a checklist for every artwork can save a company from costly errors or recalls down the line.
While the specifics can vary by region or product, most artwork checklists in pharma include the following:
Checklist Category | Checklist Items |
Product Identification | • Verify that brand and generic names are correct. |
Strength and Formulation | • Confirm the stated strength (e.g., 500 mg) is accurate. |
Composition and Ingredients | • Verify that all active ingredients and excipients are listed correctly. |
Usage and Dosage Instructions | • Check that the dosage and usage information are present and clear. |
Mandatory Safety Warnings | • Confirm presence of required warnings (e.g., “Keep out of reach of children”). |
Regulatory and Legal Info | • Ensure registration and license numbers are correct. |
Manufacturer and Distributor Details | • Verify “Manufactured by” and “Marketed by” names and addresses. |
Barcodes and Identification Codes | • Confirm barcodes and QR codes are present and scannable. |
Design Elements and Branding | • Check logos, colors, and fonts match current brand guidelines. |
Format and Layout Checks | • Match artwork to dieline/template dimensions. |
Print Specifications | • Check color codes (Pantone, CMYK) and material specifications. |
Pro Tip
Signify checklists turn complex regulations into clear, actionable tasks so your team never misses a compliance step.
Keep them updated regularly as new rules emerge to stay aligned with evolving standards and reduce the risk of non-compliance during audits or product launches.
Who Can Authenticate Pharma Artwork?
In pharmaceutical companies, artwork approval is a collaborative task, but qualified, authorized individuals must authenticate it.
Each stakeholder brings their area of expertise to ensure the artwork is accurate, compliant, and ready for production.
Regulatory Affairs (RA)
They review for compliance with health authority requirements. This includes:
Reviewing claims, symbols, and text against regulatory standards (FDA, EMA, MHRA, etc.).
Ensuring all mandatory information is present and nothing unapproved is included.
Acting as the final authority on regulatory content.
Quality Assurance (QA)
They oversee the process and issue final approval. This includes:
Verifying that internal procedures were followed.
Ensuring artwork is correct, legible, and compliant with internal quality standards.
Maintaining the approved artwork as the official “master” version.
Packaging Development & Production
They validate technical accuracy and print readiness. This includes:
Checking layout dimensions, bleed areas, and dielines.
Verifying barcodes and pharmacodes are correct and scannable.
Confirming compatibility with production and packaging equipment.
Marketing and Design Teams
They ensure the artwork aligns with brand standards. This includes:
Verifying that logos, colors, and layout follow brand guidelines.
Checking that promotional messaging is appropriate and accurate.
Making sure the design reflects the original brief.
External Stakeholders (When Required)
In some cases, outside parties must approve specific artwork. This may include:
Qualified Persons (QP) or Marketing Authorization Holders (MAH) in the EU.
Printing partners for technical or prepress sign-off.
Any region-specific roles required by regulation or SOPs.
AI Compliance Agents
Artwork approval software supports human reviewers by automating key checks. This includes:
Scanning for checklist compliance and regulatory accuracy.
Detecting outdated templates or incorrect elements.
Flagging regulatory updates that may affect the rental artwork.
Acting as a secondary review layer to reduce human oversight risks.
Best Practices for Pharma Artwork Approval
To manage the complexities of artwork review, pharma companies should adopt a structured approach.
Here are five best practices to strengthen the artwork approval process in pharma and keep it efficient and error-free:
1. Define the Key Stakeholders
The first best practice is to clearly identify all stakeholders who need to be involved in artwork approval.
The process is a team effort, and having the right mix of experts ensures your artwork meets regulatory, quality, and creative standards.
Once you’ve identified your stakeholders, it’s important to clarify their roles and determine when they should be involved in the process.
➤ Why it Matters:
Not every stakeholder needs to be involved at every stage, but without clear responsibilities, you risk confusion, delays, and rework, especially if critical reviewers are brought in too late.
➤ How Responsibilities Are Divided:
Marketing may approve early design elements, while Regulatory and QA sign off on the final text and layout.
Each team has a distinct role tied to its expertise.
➤ How to Manage It:
Establish a centralized artwork approval platform or shared workspace where all stakeholders can access the latest files, view real-time updates, and leave comments directly on the artwork.
2. Standardize the Artwork Approval Process
A consistent, repeatable process helps teams manage artwork efficiently and avoid costly mistakes.
Standardization brings structure to every project and prevents critical steps from being skipped.
➤ Why It Matters:
Without a defined workflow, teams risk delays, miscommunication, and non-compliant artwork.
That is why standardization creates a reliable framework that everyone can follow.
➤ How To Implement It:
Document the process as a Standard Operating Procedure (SOP) or create a workflow diagram.
Clearly outline each step, assign responsibilities, and define timelines.
➤ What To Include:
Step-by-step sequence (e.g., Draft → Review → Regulatory Approval → QA → Print Check).
Entry and exit criteria for each stage.
Templates for artwork requests and approvals.
➤ Why It Works:
Consistency leads to fewer errors and smoother approvals.
For example, a rule that regulatory review must happen before printing helps catch compliance issues early.
➤ Support Onboarding and Collaboration:
A clear process makes it easier to train new team members and align with external stakeholders.
Everyone knows their role and what’s required at each stage.
➤ Refine and Improve Over Time:
Use insights from past projects to strengthen your process.
If translation delays are common, add an early translation check to avoid bottlenecks.
3. Ensure Compliance With FDA and EMA Guidelines
Regulatory compliance should be integrated into the artwork process from the very beginning.
Different regions have different requirements, and understanding them early helps prevent delays, revisions, or even product recalls.
➤ Why It Matters:
What’s acceptable in one country may not be approved in another.
For example, the FDA and EMA each have strict and unique rules that affect how pharmaceutical artwork is presented.
➤ Know the Regional Rules:
FDA (U.S.): Regulations such as 21 CFR specify minimum font sizes, mandatory wording, ingredient formatting, and OTC drug facts layout.
EMA (EU): Uses QRD templates with specific rules for prescription status phrases, leaflet layout, and Braille on packaging.
If your product is global, consider using the strictest regional standards to streamline approval across all markets.
➤ Use Checklists and Style Guides:
Create internal reference tools like:
A checklist of FDA-required label items.
A style guide for presenting key elements (warnings, batch codes, etc.).
These documents help teams stay aligned and avoid last-minute fixes.
➤ Track Regulatory Changes:
Regulations evolve, so from barcode formats to updated warning statements, staying current is essential.
Assign someone, whether a team member or an AI compliance tool, to monitor updates from agencies like the FDA and EMA.
Pro Tip
Signify’s Regulatory Monitoring keeps you informed of changes to relevant laws (FDA, USDA, ISO, and over 1000 frameworks) and standards in real time.
Make it a habit to review these alerts weekly so you can proactively adapt your compliance documentation and avoid costly disruptions or non-compliance risks.
4. Centralize Artwork Reviews and Version Control
Disorganized reviews and scattered file versions are a major source of delays and errors in pharma artwork approval.
Centralizing the process and documentation keeps everything aligned and traceable.
➤ Why It Matters:
When feedback is spread across emails, chats, and personal folders, mistakes happen, people review the wrong version, comments get missed, and final files are hard to verify.
Centralization eliminates this risk.
➤ How To Centralize Reviews:
Use a shared platform or artwork management system where all stakeholders can access the latest files, leave comments, and track changes in real time.
Even structured shared drives with strict naming rules can be effective.
➤ What It Solves:
Everyone works from the same version.
Feedback is visible, contextual, and traceable.
Approved files are stored in one location with version control.
No reliance on one person’s inbox or laptop.
➤ Compliance and Collaboration Benefits:
Centralized systems provide an audit trail showing who approved what and when, which is essential for audits.
They also make cross-functional collaboration easier, as everyone views and discusses the same file simultaneously.
➤ The Result:
By managing artwork in a single hub, teams avoid version chaos, reduce errors, and speed up the review cycle.
5. Measure and Optimize Performance
The artwork approval process should evolve, meaning measuring performance helps identify issues, improve speed, and reduce the risk of errors over time.
➤ Why It Matters:
Without data, it’s hard to know where delays or mistakes happen.
Tracking performance lets you make informed improvements and spot recurring issues.
➤ What To Measure:
Average time from draft to final approval.
Number of revision rounds per project.
Percentage of artwork approved on schedule.
Common causes of delays or compliance issues.
➤ How To Improve:
Use stakeholder feedback and KPI data to find pain points.
For example, if legal review is always late, consider involving that team earlier or adjusting resource allocation.
➤ Set Goals and Make Changes:
Establish baseline metrics, then set realistic improvement targets, such as reducing average revision rounds or shortening approval time.
Small changes, like refining checklists or introducing collaborative tools, can have a big impact.
Common Challenges in the Artwork Approval Process in Pharma
Even with best practices in place, pharma teams often face recurring challenges during artwork approvals.
Here are some of the most common pain points:
Coordinating Stakeholders: Managing input from multiple departments and partners can delay approvals. Aligning timelines and tracking who’s reviewed what is often a manual and frustrating task.
Version Control Issues: Without a centralized system, teams may work from outdated files. This leads to confusion, duplicated effort, or using the wrong version in production.
Deadline Pressure: Tight launch schedules or sudden regulatory changes force rushed revisions, increasing the risk of errors slipping through.
Regulatory Complexity: Each country may have different labeling rules. What’s mandatory in one market might be restricted in another, making global alignment difficult.
Communication Gaps: Siloed teams and disconnected tools can lead to misunderstandings, duplicate feedback, or missing context during review.
Human Error: Typos, misaligned text, or incorrect codes are common when relying solely on manual checks, especially under time pressure or reviewer fatigue.
Manual Workflows: Using email and spreadsheets makes tracking progress harder. Without proper tools, it’s difficult to maintain visibility, accountability, or a reliable audit trail.
Streamline Pharma Label Checks with Signify
Signify is an AI compliance agent that automates label compliance checks quickly and accurately, helping teams meet global regulations without the manual burden.
It streamlines artwork approval by replacing outdated processes with intelligent, rule-based verification.
How Signify Supports Artwork Approval:
Break down label content and layout to ensure every detail meets compliance standards.
Build checklists tailored to your product, formulation, and target markets.
Catch gaps, errors, and inconsistencies before they cause delays.
Cut review time by up to 90% compared to manual checks.
Stay aligned with evolving FDA, EMA, and international regulations automatically.
Ready to eliminate manual label checks and reduce compliance risk?
Try Signify today for free and see how effortless the artwork approval process in pharma can be!
