Pharmaceutical Artwork, its Approval, Modification and Implementation

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Pharmaceutical Artwork

Pharmaceutical Artwork is a printing matter, which placed on pharmaceutical product’s packing material as label, carton, leaflet etc.

Pharmaceutical Artwork including the followings

  • Design part: Design part of artwork, designed as per marketing requirement and is a management’s deal.
  • Printing text matter: Printing part contains compositions, dosage, manufacturing firm’s address, Batch no., Mfg. Date, MRP, pack size and whatever required by Drug & Cosmetic Act including any regulatory rules like precautions, schedule M drug etc.

 Artwork for a New Product

  • To design a new product artwork, its dimensions final by dosage form pack size, will obtain dimensions and layout of the proposed text matters from Marketing and provide them to the technical personnel who can review the artwork and its local and regulatory packaging requirement.
  • Technical personnel will review the requirements based on the information submitted to FDA in the application for obtaining the manufacturing license and the related information of different dosage forms like tablets, injectables, creams, ointments and ophthalmic.
  • They will obtain information regarding price clause regarding code no., code bars etc. from purchase.
  • Technical personnel will compile the above information and prepare a draft for the printed material which will be submitted to purchase for sending it to marketing who will arrange for making the artwork or can send it directly to artwork designer.
  • Purchase will receive the artwork from marketing or designer and will submit it to technical staff for its approval.
  • Any correction, if required, in the artwork will be communicated to purchase in writing.
  • At the time of final approval, technical personnel will also approve the color scheme for the printed materials.
  • Purchase or concerned will submit the final approved artwork to marketing or artwork designer & printing vendor for arranging to make them finalize and arranging a shade card for color scheme approval before printing the consignment, copies of which will be distributed to QC lab for checking of next coming consignment.
  • Shade card sent by vendor to mfg. firm should approved by a technical staff.
  • Approved shade card and artwork will be a checking material against next coming consignment sent by vendor for same product. These approval are the part of packing material analysis by Quality control of firm.

Modification in Artwork for Existing Products

Changes in the test matter of the printed materials of the existing products may be required due to following reasons :

  1. New statutory requirements.
  2. Change with respect to pharma suffix, preservative content or type of preservative.
  3. Change in price clause.
  4. Change in manufacturer’s address
  5. Change in color scheme or layout.
  6. Or design change required by management or marketing.

Procedure for Modification in Artwork

  • Respective departments initiating changes will send a request to purchase for incorporating the same.
  • Purchase or relevant personnel will send a requisition for change in writing to technical personnel, who will review and approve the changes for incorporating in the artwork if found appropriate.
  • The approval authority will finally approve the changed artwork. Purchase or relevant personnel will send the final approved artwork to marketing or artwork designer and then to printing vendor for arranging to fix the changes , copies of which will be distributed to technical personnel for final approval.
  • After approval, a new shade card (if color scheme changed) will finalize and approved.
  • New artwork approval and new approved shade card now replace with old one for the same product in quality control packing analysis section.
  • Changes to be done through change control procedure, change only can be implemented if changes are approved by quality assurance and relevant technical personnel.

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