This SOP for Artwork Management in pharmaceuticals ensures that all artwork related to our products meets regulatory requirements and is consistently high quality. This includes processes for artwork creation, review, approval, storage, and guidelines for version control and change management. By following this SOP, we can ensure that our pharmaceutical packaging and labeling comply with all relevant regulations and standards while maintaining a professional and consistent brand image.
Preparation and Handling of Artwork
1.0 Purpose:
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- The purpose of this SOP is to define a procedure for Artwork preparation, Review, Approval, and version control of Drug Products in pharmaceuticals.
2.0 Scope:
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- This procedure applies to Artwork preparation for domestic and export markets. Artworks are for products that are sold in India and the export market.
3.0 References:

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- WHO TRS 902 – Annex 9 – Guidelines on packaging for pharmaceutical products.
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- In – House
4.0 Procedure of Management of Artwork:
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- Activity and responsibility of Artwork Management is given below:
S. No. | Activity | Responsibility |
1 | Request for artwork | Marketing / Production |
2 | Receipt of request by QA | …………. |
3 | Text matter development & size of packing material | QA / Production |
4 | Sending text matter to marketing/export | QA |
5 | Making of artworks | Marketing |
6 | Receipt of artwork by QA | ……… |
7 | Checking/Review (as per Annexure I) | QA/QC/Production |
8 | Issuance and retrieval of shade cards / Artwork. | QA/QC |
9 | If corrections are there sending back to marketing/export | QA |
10 | Receipt of corrected artwork by QA | ……. |
11 | Approval of artworks | QA/QC/Production |
12 | Sending approved artworks to marketing/export | QA |
13 | Communication regarding colour scheme to purchase department | Marketing |
14 | Receipt of printed proof duly approved by marketing/export for the color scheme by QA | Purchase Department |
15 |
Checking of printed proof |
QA/QC/Production |
16 | Corrections if required, communicated to the purchase department | QA |
17 | Receipt of corrected printed proof duly approved by marketing/export for the color scheme | ………. |
18 | Approval of printed proof | QA/QC |
19 | Intimation to purchase department about printed proof | QA |
20 | Final Printing | Purchase Department |
21 | Receipt of packing materials | Stores |
22 | Sampling & analysis | QC |
23 | Acceptance/rejection | QA/QC |
24 | In case of changes in artwork required due to machine change / change parts / statutory requirement/amendments/pack change, new artwork is to be prepared as per the above procedure | QA/QC/Production |
25 | When new artwork is issued old artwork, old plates, and old cylinders are to be withdrawn from the printer(s) | Quality Assurance |
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- If artworks belong to an external agency and shall be reviewed or approved by an external agency or QP/ MA holder, the Export department shall coordinate with the external agency or QP/ MA holder and arrange that correction or approval from the external agency or QP/ MA holder and shall be forwarded to the export department for further processing.
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- This process shall continue until approval is granted.
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- Customer-approved shade cards shall be issued to QC as such.
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- The final artwork will be printed and shall be stamped as approved.
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- The template of the stamp is given below:
APPROVED ARTWORK
Date: …………………………. Approved By QA
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- Approval shall be given through email.
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- These approved artworks shall be maintained by the QA department and reference copies shall be issued to the packing material testing laboratory.
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- After receipt of the approved artwork, the marketing department shall forward the approved artwork in non-editable format (CDR) along with a PDF file of the approved artwork to the purchasing department.
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- The purchase shall arrange print proof / digital print proof to QA for approval, and after approval purchase shall coordinate with the vendor for the arrangement of shade cards.
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- Purchase shall submit 4 sets of shade cards to the marketing department for approval.
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- The marketing department shall check the shade cards against approved artworks for shade card approval (all shades i.e. Light/ standard/ Dark, Shall be approved and signed by the Marketing department).
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- After the Marketing department’s approval, proofs/ shade shall be forwarded to purchase for final processing of the artworks.
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In the case of foreign language artworks (other than English), the printer must supply positive for checking of print proof/ shade card & text matter.
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- If shade cards are rejected for any reason, the marketing department shall submit the rejected shade cards to purchase to forward the same to the vendor.
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- The vendor shall submit fresh shade cards for approval after making the required corrections to the marketing department through purchase.
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- The Marketing department shall put an approved stamp with the name and along with validity on the approved shade cards and send them back to purchase for further coordination.
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- One set of shade cards shall be retained by the marketing department for reference.
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- The purchase shall ensure that shade cards are available at the location before the consignment reaches the location.
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- The remaining two sets of shade cards shall be supplied to the vendor through the purchasing department for future reference.
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- Whenever there is a revision in the existing artwork, as soon as the revised approved artwork is received, the concerned departments shall destroy the obsolete shade cards).
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- The validity of the shade cards is two years.
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- All the shade cards shall be replaced by a new shade after two shade cards to the vendor through the purchasing department.
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- QC shall approve the shade card after matching the Panton color and final approval shall be done by QA.
SHADE CARD APPROVAL
Date of Receipt: ………………………….
Valid Up to (2 Years):………………………
Sign by QC Sign by QA
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- Vendors shall submit actual printed sheets and positive to QC along with the first commercial supply for checking of total text on the printing plates/ cylinders as mentioned below:
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- For carton/label/leaflet: the sheets shall contain the total number of ups for which the plates are being prepared.
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- For foils/ laminates: the actual sample shall cover the total circumstances of the cylinder prepared.
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Revision of Artworks:
- Artwork can be revised due to:
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- Change in the size & dimensions.
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- Text matter/ logo/ brand Name/ Pack Size
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- New statutory requirement
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- Change in color scheme, design, design, and layout
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- Any other change
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- Based on the requirement, any change in the approved artwork shall be routed through the change control process.
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- The initiating department shall raise change control and shall send it to the marketing department for further development.
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- QA shall create new item codes as per SOP and marketing shall revise the Artwork.
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- The revised item codes shall be updated in BOM by QA.
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- If required the changes shall be informed to concerned QP/MA holder/ Regulatory agency/ customer for the changes, and impact on the product, and suggested changes shall be incorporated into artwork through change control.
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- The procedure mentioned above (New artwork generation) shall be followed for the artwork approval.
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- If the existing stock can’t be used, it will be destroyed with the consultation of Production, Marketing, and Purchase.
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- Based on the impact analysis of the change, suggested by an external regulatory agency, QA/MA holder, if the existing stock is going to be consumed then location QA in consultation with the Export Department shall confirm to production planning and Marketing for the usage of the existing stock.
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- Old artwork material shall not be mixed with new artwork material in the same batch.
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- If the quantity is not sufficient to pack the complete batch, then the new artwork shall have a different batch number.
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- If old artwork material is to be used, the same shall be used as per Annexure-III.
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Record for issuance and retrieval of approved Shade card / Artwork.
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- After approval of the shade card by QA, the approved shade card shall be issued to the QC department and the record shall be maintained as per Annexure-IV.
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- After approval of the Artwork, a reference copy shall be issued by QA to the QC department and the record shall be maintained as per Annexure-IV.
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- During the revision of the Artwork / Shade card, old copies shall be retrieved before the issuance of a new one and the record shall be maintained as per Annexure-IV.
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- Marketing shall ensure through the purchasing department that old artwork CDR (with positive & cylinder and other printing aids) was destroyed at the attached the same to the obsolete artworks control log as per Annexure-II.
5.0 Annexure (s)
Annexure I: Checklist for checking of Artwork
S. No. | Checks | Requirement / Reference | Remark |
1. | Product Name in English & Hindi | From Marketing | |
2. | Generic Name | Font Size shall be similar or at least two font sizes larger than the brand name or the trade name. In case the Product has three or more API compositions then the Brand name shall be in the Bracket. |
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3. | Product Composition | As per license | |
4. | Packing | Marketing | |
5. | Dosage | Drugs & Cosmetic Act/Tender Document | |
6. | Storage | IP/BP/USP/ Manufacturer in bold form | |
7. | Keep out of reach of children | Standard warning | |
8. | Trade Mark & Bar Code | As per List (from HO) | |
9. |
Scheduled Requirement |
If the drug falls in Schedule – G, then the prescription of G shall be in a red rectangular box in black color. | |
If the drug is Schedule H then a warning of Schedule H with Rx shall be printed. | |||
If the Drug falls in both Schedules (H & G) then a warning of both schedules is to be printed with Rx. | |||
If any drug does not cover G&H, only caution of Schedule H or G shall be written in Red Box with black color without Rx after discussion with the technical team | |||
10. | Address of Manufactured By | ||
11. | Address of Marketed By | ||
12. | Size (For Foils check repeat also) | Mock Up | |
13. | Mfg. Lic. No. \ Neutral Code | Product Permission of Product | |
14. | For Vitamins write,
For Therapeutic Use / Prophylactic Use |
As per license / Drugs & Cosmetics Act | |
15. | Coding details | Production | |
16. | For Paracetamol Preparations | Overdose of Paracetamol may be injurious to the liver. | |
17. | For Diclofenac Preparation | Warning: “Not for Veterinary Use” | |
18. | Address of Marketed By | ||
19. | Additional for Liquid Preparation | Shake well before use
Keep bottle well closed |
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20. | Specific Precaution/warning | ………. | |
21. | Specimen if any on which the artwork is designed | ………. | |
22. | For Enzymes / Vitamins | Appropriate overages are added to compensate for loss of storage. | |
23. | Item Code | ……….. | |
24. | For Physician Sample | Physician’s Sample Not To Be Sold, In red color | |
25. | Varnished/laminated / board quality | Marketing | |
Specific Requirement : | |||
26. | Tender Requirement (If any) | Check the tender documents for additional information to be printed on Pack | |
Claim | |||
Dosage | |||
Antimicrobial agents, antioxidants, artificial sweeteners, and allergens are required to be printed, check it from approved BOM. | |||
27. | Others |
Reference Document:
- License Copy
- Approved BOM
- ………….
Annexure II: Format For Confirmation of Destruction of obsolete Artworks and process
From: Packaging Development
To: (Name, Address, Vendor/ Supplier)
Through: Purchase
Dear Madam/ Sir,
This is to inform you that we need to destroy the proofs & other printing processing aids for the below artworks as per the given details, and further, all existing artworks about superseded item code/s at your end (i.e Hard copies, CDR, and copies in computers), their positives, plates, cylinders and other process aids (if any) must be destroyed before initiating work on the new request.
Sr. No. | Artwork Code No. | Superseded Artwork Code No. | Description | Remarks |
Please send the below acknowledgment as a confirmation that the request of destruction has been carried out at your place. The same will be confirmed by our representative during the next visit to your establishment.
(Authorized Signatory)
Packaging Development
ACKNOWLEDGEMENT
To: Packaging Development
From: Name, Address, and Vendor Code of Supplier
Through: Purchase
Dear Madam,/ Sir,
This is to inform you that consequent to your request dated DD-MM-YY, we have destroyed all existing artworks (hard copies, compact discs, and copies in computers), positives, plates, and other process aids about the superseded item code (s):
Sr. No. | Superseded Item Code | Description |
Your representative may physically verify that the destruction has been duly carried out at any time.
(Authorized Signatory)
Vendor/ Supplier
Annexure III: Use of Old Artwork Material
Item Description | Item Code | Details of Change | A.R. No. | Quantity | Quantity equivalent to batch size | Remarks |
Annexure IV: Record of shade card & Artwork
Sr. No. |
Item Code | Product Name | Vendor Name |
Description (Label / Literature / Carton / Foil) |
Item |
Issued By (QA)
Sign / Date |
Received By (QC)
Sign / Date |
Retrieved By (QA)
Sign / Date |
Remarks
(If any) |
Shade Card /Artwork | ||||
Shade Card /Artwork | ||||
Shade Card /Artwork |