Freeze the technical brief before artwork

Confirm molecule, supplied form, fill, pack, documentation and destination constraints before label copy is treated as final. Otherwise every technical change creates artwork rework.

Version artwork components

Maintain controlled versions for vial label, carton, insert and master case. Required fields, RUO wording, lot/expiry placement, languages and barcode rules should be reviewed against the destination brief.

  • Vial and carton dielines
  • Copy deck and translations
  • Lot, manufacture and retest/expiry fields
  • Barcode or QR requirements
  • Print proof approval

Release the pack and the batch together

The packing configuration, label version and released-lot documents should reconcile before dispatch. The final handoff should identify exactly which versions shipped.

Primary references

ICH Q10 Pharmaceutical Quality System