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Friday, May 7, 2010

STANDARD OPERATING PROCEDURE Title: ARTWORK CHECKING

1. Purpose
a) This guideline describes the factors to be considered in making artwork and follow up inspection by Quality control department to avoid mistakes in artwork.
2. Scope
a) This guideline is applicable to all Global Pharmaceutical products.
3. Responsibilities
a) QC Manager
b) Asst. QC Manager
4. Procedure
To generate an Artwork for a new product, Product Manager works in collaboration with QC manager.
Product Manager provides design and color scheme, while QC Manager provides text according to the registration.
These points must be considered while developing or checking of Artwork for a new product:
1. Product name in Urdu and English on all sides and flaps.
2. Generic name in 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. Urdu version
19. Mfg. Lic. No.
20. Registration No.
21. Batch No.
22. Mfg. Date
23. Expiry
24. Retail price
25. Grammage of card
26. Thickness of Card
27. Font size
28. Font style
29. Dimensions
30. Thickness
31. Over printing box
32. “ISO 9002 Certified Company”
33. “Shake well before” use in case of suspension only

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