Artwork approval is a crucial step for regulatory affairs (RA) professionals in labeling and packaging. Even minor oversights can lead to non-compliance, costly product recalls, and submission and product launch delays. To help navigate this complex process, we’ve compiled an essential artwork approval checklist that will streamline approvals, ensure compliance, and protect brand integrity.
1. CONTENT ACCURACY
Why It Matters
Content accuracy and consistency across markets and formats is not only a regulatory requirement. Healthcare professionals and consumers depend on accurate and clearly written and presented information on labeling and packaging. Even a minor error or inconsistency in a label – such as a typo in dosage instructions – can place patients at risk, lead to costly litigation, result in a product recall, and damage the reputation of your company and the brand. With the phasing-in of e-labeling (e.g., package inserts available online) and wider range of formats in many regulatory jurisdictions today, the risk of error and inconsistency has increased significantly. So, too, has the complexity for regulatory affairs professionals. (Don’t forget: Promotional material must also be accurate and consistent with approved materials.)
Key Actions
Verify product information
• Product names, active ingredients, strength, dosage forms and other critical information are correct.
• All product information on indications and usage is consistent with approved claims and regulatory filings of labeling and packaging.
Check legal statements and warnings for accuracy
• Appropriate warnings, precautionary statements, contraindications, and instructions meet regulatory requirements and guidelines.
Check expiration dates and batch numbers
• Correct placement and required readability of all traceability information, such as batch numbers and expiration date.
Best Practice
Create watertight verification processes and automation: Leverage tools like TVT to compare artwork versions and detect any deviations from approved documents before moving artwork forward. This is also important for ensuring accuracy and consistency across your formats and markets (e-labeling, physical versions, promotional material).
2. REGULATORY COMPLIANCE
Why It Matters
Achieving compliance is the legal and regulatory entitlement for your business to operate. Despite harmonization efforts, markets have their own specific regulatory requirements. Non-compliance is costly and time-consuming, and above all it might risk the efficacy of treatments and health of the patient. Regulatory affairs professionals must ensure that packaging, labeling, and documentation align with the requirements of the regulatory jurisdiction, and are aligned with regulations for the specific format (i.e., physical or online). Here it is important to monitor and understand changes to regulations in specific markets and jurisdictions, and have processes in place for change.
Key Actions
Confirm labeling requirements
• All information (e.g., dosage, storage conditions, manufacturer information) is compliant, meets requirements, and has been verified for the specific market.
• Key font and style aspects in particular conform to regulatory requirements or guidelines (e.g., font size, legibility, barcode placement and readability), especially for critical information.
Ensure language accuracy
• Required language versions have been developed for the specific market, including multiple language versions (e.g., for Canada or Switzerland).
• Accredited translators with experience in the field have been used.
• Translation validation processes are in place and the translation has been verified.
Check country-specific symbols
• Mandated symbols for the region are correct (e.g., CE mark in Europe), and specific logos are correct and meet quality standards.
• Placement of logos and symbols is correct
Ensure version control readiness for physical and electronic formats
Processes are in place for real-time updates of electronic labeling and for physical labeling updates when regulatory requirements in a market change.
Best Practice
Understand the different regulatory requirements. Monitor regulatory environments and changes. Appoint responsible persons (knowledge owners) for specific regulatory jurisdictions. Create clear regulatory interfaces (regulatory bodies like the FDA encourage proactive consultation). Establish clear roles and interfaces with regulatory bodies, and consult. Set up periodic training sessions for your RA team to stay updated on evolving regulations in different markets.
3. ARTWORK INTEGRITY
Why It Matters
This takes in the accuracy, consistency and compliance of packaging and labeling artwork throughout the approval and production process. Often it is difficult to notice small errors in artwork with the human eye, and yet even the smallest deviation in image and graphical elements can lead to non-compliance, or impact branding and patient recognition. Problems here can range from illegible barcodes to corporate logos that are not compliant with internal guidelines.
Key Actions
Use automated comparison software
• An automated tool has been used to detect any deviations between the approved text and artwork version and the subsequent downstream versions.
Verify barcode readability
• Barcode readability has been verified on a pass/fail basis. All barcodes (1D and 2D codes ) are correct and functional for traceability and to prevent counterfeiting.
• QR codes lead to correct online versions for e-labeling.
Verify all visual elements
• Images, logos, and other visual elements meet quality standards
• Elements are in the correct format, and align with brand requirements.
Best Practice
Don’t rely on the human eye. Invest in an industry-recognized automated tool that meets ISO 9001:2015 standard for Design and Software Development for Regulated Environments.
4. BRAND AND DESIGN CONSISTENCY
Why It Matters
Following on from Artwork Integrity, branding and design are your assets and have tangible financial value. For this reason, most companies have internal branding and design guidelines that ensure consistency and uniformity across the company, its products and stockkeeping units (SKUs). While regulatory affairs professionals deal with the nuts and bolts of compliance, collaboration with design and marketing teams is important for ensuring compliance with corporate guidelines. Care for your product and brand assets!
Key Actions
Verify that brand guidelines are being met
• Logos, colors, fonts, and layout adhere to guidelines, including cross-product guidelines (e.g., corporate logo) and product branding guidelines (e.g., product logos).
Check that all design elements are consistent across SKUs
• Layout, design and all information are consistent across SKUs.
• Online and physical branding and design elements are consistent.
Make sure that graphic sensitivity levels have been correctly set Software sensitivity levels are set to the required level of sensitivity, thus avoiding subtle differences in color and graphics.
Best Practice
Conduct regular brand audits. Review labeling and packaging across all markets to ensure compliance with both regulatory and brand consistency requirements. This review can be conducted quickly and with utmost accuracy if supported by automated document comparison software such as TVT Artwork.
5. TECHNICAL AND QUALITY CONTROL
Why It Matters
High-quality artwork files minimize printing issues and promote a culture of high professionalism. Getting it right early on is imperative as it saves waste, reduces resource use, saves time and prevents avoidable delays in production and marketing.
Key Actions
Check file format and resolution
• Artwork files meet print specifications, especially in terms of file format (e.g., PDF) and the required resolution.
Make sure that artwork complies with printing standards
• Color, bleed, trim and cut lines meet requirements, thus avoiding downstream delays.
• Final review of proofs has taken place to make sure that all changes have been applied and no new errors have been introduced.
Best Practice
Work closely with printers. Establish clear interfaces and ensure that communication with vendors is in place and runs efficiently, thus avoiding ambiguities and misunderstandings that might lead to errors.
6. APPROVAL DOCUMENTATION
Why It Matters
A well-documented approval process ensures transparency, accountability, and regulatory compliance. During audits, missing or incomplete documentation of approval actions and identifiable responsible persons can lead to legal risks and operational inefficiencies.
Key Actions
Make sure you have approval signatures
• All key stakeholders have signed off the artwork and other regulatory documents.
• All required signatures and approvals comply with regulatory standards.
Ensure comprehensive version control
• All document changes have been properly recorded to prevent outdated materials from being used.
• The latest version is clearly marked and documented as such.
Make sure you have an audit trail and change log
• All changes to labeling and packaging have been logged, ensuring complete traceability for regulatory audits.
Best Practice
Implement software that supports version control and, if required, integrates into your larger information management system and workflows. Establish a standard nomenclature for version control and provide training on its proper use.
7. POST-APPROVAL VERIFICATION
Why It Matters
Regulatory requirements change as circumstances change – especially in the pharmaceutical industry, where new knowledge becomes available the longer a product is on the market. And remember: regulations are also changing even while you are developing your labeling and packaging. Taking a proactive approach will avoid issues that might be costly down the line.
Key Actions
Pre-marketing check
• Final review of regulations has been conducted to ensure you are working with the most recent regulatory versions.
• Labeling and packaging complies with the current regulations and guidelines.
• Final pre-print check of labeling and packaging has been performed to ensure there are no deviations (errors) from the approved version.
Post-market surveillance
• Monitoring and feedback collection steps (patients, healthcare providers, sales teams) are in place to understand any labeling and packaging artwork issues as they arise.
• Proactive response planning is in place (responsible persons in specific markets) to implement required changes due to artwork issues.
Confirm compliance
• Ongoing post-marketing regulatory monitoring is taking place across different markets.
• A clear interface exists between those responsible for monitoring regulations and those implementing downstream change.
• Artwork is verified on an ongoing basis in accordance with changes to regulations in the market and fed into a feedback loop.
Best Practice
Create a holistic approach to post-approval verification, taking in monitoring regulatory change in the target markets, monitoring and proactively collecting responses in the market from key stakeholders, and proactively putting processes in place (including crisis planning) to implement changes quickly.
CTA: If you would like to find out how TVT and its modules TVT Artwork, TVT Barcode and TVT Spelling can help you, get in touch with us.
