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 applies to all PharmaInfo products.

Responsibilities

QC Manager

Asst. QC Manager

Procedure

• To generate Artwork for a new product, the Product Manager collaborates with the QC manager.
• The Product Manager provides the design and color scheme, while the 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.

Annexure

Nil

Revision History

Nil

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