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SOP for Artwork Checking

Purpose
This SOP describes the factors to be considered in making artwork and follow-up inspection by the Quality control department to avoid mistakes in the artwork.

Scope
This SOP is applicable to all Pharmasky products.

Responsibilities
QC Manager
Asst. QC Manager

Procedure
  • To generate Artwork for a new product, the Product Manager works in collaboration with the QC manager.
  • The Product Manager provides the design and color scheme, while QC Manager provides text according to the registration.
  • These points must be considered while developing or checking Artwork for a new product:


  1. Product name in English on all sides and flaps.
  2. A generic name in a bracket.
  3. Reference of pharmacopoeia
  4. Dosage form Tablet/Capsule/Suspension/Cream/Ointment and Injection.
  5. Coating Status (Enteric coated, Sugar coated or film coated), in case of tablets only.
  6. Pack size
  7. Monogram
  8. Lines/Band color/printing color.
  9. Band size
  10. Instructions related to medicine
  11. Storage conditions
  12. Keep all medicines out of reach of children
  13. Manufactured by
  14. Packed by
  15. Marketed by
  16. Manufactured for
  17. Any additional stamp (Physician sample/Not for sale, Govt. supply etc.)
  18. Mfg. Lic. No.
  19. Registration No.
  20. Batch No.
  21. Mfg. Date
  22. Expiry
  23. Retail price
  24. Grammage of card
  25. Thickness of Card
  26. Font size
  27. Font style
  28. Dimensions
  29. Thickness
  30. Over-printing box
  31. “ISO 9002 Certified Company”
  32. “Shake well before” use in case of suspension only.

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