In pharma, artworks are the controlled master designs for all printed packaging components—cartons, labels, foils, leaflets, shippers, inserts, booklets, and sometimes on-pack overprint layouts. They translate the approved product information (name, strength, composition, warnings, storage, manufacturer details, batch/expiry fields, barcodes/2D codes) into a print-ready format and are treated as critical GMP documents because artwork errors can directly cause mislabeling and patient harm.
Artwork management typically starts with an Artwork Request raised by Regulatory/Marketing/QA for a new product, new market, variation (e.g., PI change), vendor change, or serialization requirement. The request defines the pack configuration, language, legal text, and coding requirements. A draft is created (often by an internal team or agency) and then reviewed through a controlled workflow. Cross-functional review usually involves Regulatory Affairs (label claims and compliance), Quality Assurance (GMP, traceability, readability, ALCOA+ documentation), Production/Packaging (line feasibility, coding space, carton/foil fit), and sometimes Supply Chain (SKU harmonization).
Key controls include:
- Unique artwork number and version control, with history of revisions and effective dates.
- Text verification against the approved label text/SmPC and approved variations.
- Proofreading (two-person independent check) and “golden sample” approvals.
- Barcode/2D code verification (format, data string, scan grade requirements).
- Change control and impact assessment (existing stock disposition, cut-in date, rework rules).
- Controlled distribution to printers and to the packaging line (only current version issued).
- Reconciliation and destruction of obsolete printed materials to prevent mix-ups.
During inspections, regulators often sample artwork governance alongside Batch Packaging Records (BPR), line clearance, and printed material reconciliation, because artwork failures frequently lead to market complaints, returns, and recalls. A mature artwork system therefore links tightly with the Pharmaceutical Quality System, deviation/CAPA, and supplier qualification for printers and packaging vendors.