Use this checklist to walk a label or packaging artwork from approved content to print-ready release. It follows the workflow covered in the Pharma Artwork Approval guide, condensed into the checks that matter most, and applies across pharma, medical devices, medical marketing, and FMCG/CPG.
This checklist is a working reference, not a substitute for the regulations or your own SOPs. Adapt it to your quality system.
1. Before Artwork Starts
☐ The approved source content (regulatory text, IFU, claims, formulation-linked declarations) is locked as the master
☐ The master has a unique version identifier that can't be reused or edited
☐ The change request states what is changing, why, and who requested it
☐ All affected SKUs, pack sizes, languages, and market variants are identified up front
☐ Reviewers and approvers for this change are named
2. Artwork Creation
☐ The artwork is built from the current master version, not a copy of a previous artwork file
☐ Required symbols, barcodes, and Braille are specified before layout begins
☐ Text is kept live (not flattened into an image) wherever it needs to be verified
3. Text Verification
☐ Every language version has been compared against the approved master at the character level
☐ Dosages, strengths, warnings, and storage conditions have been checked specifically
☐ The comparison covers every character, not just the section that was changed
☐ Every deviation has been reviewed and marked as intended or corrected
4. Graphics and Layout
☐ Logos, images, and layout have been compared against the approved artwork
☐ Required symbols are present, correctly sized, and from the current standard version
☐ Any required highlighting or emphasis (such as allergen bolding) survives in every language version
5. Barcodes and Braille
☐ Every barcode decodes to the correct, approved data (GTIN, NDC, UDI, or equivalent)
☐ Barcodes have been graded to the applicable ISO/IEC quality standard
☐ The human-readable text matches the encoded barcode data
☐ Braille content has been verified against the approved text (where required)
☐ Barcode and Braille checks ran in the same review as text and graphics, not as a separate afterthought
6. Languages, Markets, and Packaging Levels
☐ Every variant traces back to the same master version
☐ Variants have been compared against each other, not only reviewed individually
☐ Market-specific content (local regulatory statements, representatives, units) has been checked per market
☐ Every packaging level (unit, carton, case) is consistent with the others
7. Review and Sign-off
☐ Every reviewer reviewed the same version, and that version is identified in the approval record
☐ Approval is tied to the specific version identifier, not a file name
☐ Any change made after a reviewer signed off has restarted review for that reviewer
☐ Electronic signatures are attributable to named individuals, meeting 21 CFR Part 11 where applicable
8. Release to Print
☐ The file sent to the printer is the exact approved version, verified against the master one final time
☐ No late edits have been made since final approval without a new comparison
☐ The printed proof has been compared against the approved digital file
9. After Release
☐ Superseded versions are withdrawn and archived, and can't be issued for a reprint
☐ The printer or vendor has been told which version is current
☐ A periodic review date is set for this artwork
10. Audit Trail
☐ Every comparison, deviation, resolution, and approval is recorded with a timestamp and user
☐ The record links each step to a specific document version
☐ The full review history can be retrieved without searching email or shared drives
Industry Notes
Pharma: In the EU, the medicine's name must appear in Braille on the outer packaging. Check that NDC formatting is consistent across carton, container, and prescribing information, especially as labels move to the 12-digit NDC format.
Medical devices: Confirm UDI consistency across every packaging level and that symbols follow the current ISO 15223-1 edition. The Medical Device Labeling Audit Readiness Checklist covers device-specific checks in more detail.
Medical marketing: Check claims word for word against the approved source, and confirm every MLR reviewer approved the same version. We cover why this goes wrong in Promotional Review Has a Version Problem Nobody Is Fixing.
FMCG/CPG: Check allergen declarations and highlighting in every language, and that any environmental claims removed under the EU's new green claims rules are gone from every variant. The FMCG/CPG Packaging Compliance Checklist covers EU packaging requirements.
If any item above is unchecked, that's the point to fix before release. The most common gap isn't a missing review. It's a review done on the wrong version, or against the previous draft instead of the master. Our Document Version Control guide explains how to close it.
Content Compare runs text, graphic, barcode, and Braille verification against your approved master in a single session, with a timestamped audit trail for every comparison. See how it works on your own artwork.